ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Business Development Director to join our internal team in the US, preferably on the west-coast. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As Business Development Director, you will be responsible for lead generation, opportunity assessment, creating new accounts and growing existing accounts. Previous experience working with a global Contract Research Organization and selling full service global CRO services is required.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Identify, assess, and pursue new business opportunities.
Previous experience selling full service CRO services is required.
Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.
Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.
Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.
Work to exceed revenue targets that align with the company's growth objectives.

Education, Experience and Skills:

6+ years of sales and account management experience
Established a network of decision-makers in the life-sciences industry.
Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.
Strong negotiation skills with a proven track record of closing complex business deals
Persuasive and compelling presentation and communication skills, both written and verbal
Ability to interpret business challenges and present quick and responsive high-level solutions.
Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.
Positive employer and client references
BA, MBA, or equivalent experience

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account management

#LI-VH1 #LI-Remote TBD #LI-Director #LI-FULLTIME

","jobSummary","ClinChoice is seeking a Business Development Director to lead new business opportunities and grow existing accounts. The role requires experience in selling full-service CRO services, building relationships with senior stakeholders, and contributing to the company's growth objectives. Join us to make a meaningful impact in global healthcare.","metaDesc","Lead business development efforts at ClinChoice, a global CRO, by identifying new opportunities, managing client accounts, and driving revenue growth through strategic account planning and effective communication.","benefits",[2094,2095,2096,2097],"Professional Development Opportunities","Excellent Work-Life Balance","Global Collaboration","Flexible Remote Work Options","applicationUrl","https://boards.greenhouse.io/clinchoice/jobs/4527451101?utm_source=remoteliz.com","skills","Source","ExternalID","ExternalURL","2025-02-02T05:18:36.847359-05:00","lastCheckAt",{"_855":2107,"_2041":2042,"_2043":2108,"_2045":81,"_2046":2109,"_2054":2111,"_13":2112,"_2062":2063,"_2064":2113,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2115,"_2086":2116,"_2088":2117,"_2090":2118,"_2092":2119,"_2098":2123,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2124,"_2105":2042},448,"Program Coordinator Consultant",{"_16":81,"_18":2110,"_20":2110,"_22":-5,"_2049":2029,"_2050":-5,"_2051":2052,"_2053":2028},"2025-01-07T11:01:27.287081-05:00",[],[],"2025-01-28T09:57:51.02853-05:00",0,{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Program Coordinator Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

Create and maintain integrated cross functional project plans, forecast and demand projections, and scenario plans in Planisware.
Create, maintain, and distribute scope control reports.
Provide tracking and reporting of EP Metrics.
Collaborate with cross functional team members in the Project Management Team.
Engage in cross organizational partnerships and collaboration with key business partners.
Participate in continuous process improvement initiatives.

Provide coordination support to the Project Management and Clinical functional teams assigned to ensure completion of deliverables that are balanced for quality, timelines and resources.
Create and maintain cross functional project plans and team reports and provide resource management support to ensure the completion of deliverables balanced for quality and timeliness.
Schedule and maintain regulatory filing, approval, and launch strategy related milestones.
Facilitate critical path analysis and optimization planning. Assist team in determining schedule and resource requirements.
Build, maintain and share key event maps from Planisware.
Assist the Program Manager in providing short term and long-range planning, resource, forecast and demand management support to the Compound Development Teams (CDTs).
Facilitate team communications by maintaining and tracking cross-functional timeliness, deliverables, and milestones including cross project dependencies.
Generate program reports and communications to ensure team and program alignment of deliverable expectations.
Assist functions in determining schedule and resource requirements.
Conduct contingency planning and scenario analyses and propose opportunities to accelerate planning and optimize resource allocation.
Conduct scope control analyses from a planning and forecasting perspective and translate the data to insights in reports.
Identify continuous process improvement opportunities concerning the planning and forecasting environment.

Education and Experience:

A bachelor’s degree in scientific or business management discipline is required; a post-graduate degree is preferred.
Commanding knowledge of and experience with MS Project, Planisware, or similar planning tool, is required.
Knowledge of and experience with pharmaceutical product development, clinical development, and lifecycle management is required.
Hands on experience with extracting knowledge and insights from structured and unstructured data is preferred. This may include design thinking, robotic process automation, generative artificial intelligence, data mining, visualization, predictive analytics, and/or big data analytics.
Clear and transparent communication, organization, self-awareness, interdependent partnering and collaboration, and stakeholder management are required skills and abilities.
Previous experience with working in a global matrix organization with cross functional teams and cross organizational business partners is preferred.
Experience with process excellence is preferred.
Management Professional (PMP) or another project management certification is preferred.
Planisware and Microsoft Project.
PMP certification

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Plainsware, MS Project, Lifecycle Management, PMP

#LI-PB1

#LI-Remote

","ClinChoice is seeking a Program Coordinator Consultant to join their team. The role involves creating and maintaining project plans, tracking metrics, collaborating with cross-functional teams, and supporting program management activities. Candidates must have a bachelor's degree in a relevant field, experience with MS Project or Planisware, and knowledge of pharmaceutical product development. The position offers opportunities for professional growth within a supportive global organization.","Support clinical development programs by managing project plans, tracking metrics, and collaborating across teams at ClinChoice.",[2120,2121,2122],"flexible work options","equity in a fast-growing company","travel stipends","https://boards.greenhouse.io/clinchoice/jobs/4525217101?utm_source=remoteliz.com","2025-01-28T10:40:16.960764-05:00",{"_855":2126,"_2041":2042,"_2043":2127,"_2045":89,"_2046":2128,"_2054":2130,"_13":2132,"_2062":2063,"_2064":2134,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2135,"_2086":2136,"_2088":2137,"_2090":2138,"_2092":2139,"_2098":2140,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2141,"_2105":2142},12419,"Principal Statistical Programmer – Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},"2025-01-07T11:01:27.288329-05:00",[2131],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2133],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-26T05:06:14.128413-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

We are seeking a Principal Statistical Programmer to join our growing team in Late Phase Clinical - Cardiovascular, Renal, and Metabolism (CVRM). This is a leadership role responsible for the strategic direction and delivery of programming activities across complex clinical development programs. As a subject matter expert, you will guide teams in the implementation of statistical programming and provide technical leadership across a range of drug development projects.

You will be expected to lead the full scope of programming activities, ensuring the highest quality deliverables and efficient project delivery, while driving continuous improvement within the programming discipline.

Main Job Tasks and Responsibilities:

Leading and directing the full scope of programming delivery for projects or technical initiatives within the CVRM therapeutic area, ensuring alignment with project timelines, quality standards, and objectives.
Implementing statistical programming aspects of clinical protocols or development programs, providing expert guidance to the team and ensuring proper execution.
Ensuring the high quality of all project deliverables, holding external partners and providers accountable for their contributions, and acting as a technical subject matter expert for specific therapeutic areas, projects, or functions.
Driving the development of best practices in programming to improve quality, efficiency, and effectiveness within the function, fostering innovation in programming methodologies.
Leading or contributing to cross-functional process improvement initiatives, bringing forward solutions that enhance overall team performance.
Driving the development and implementation of programming standards, ensuring consistency and compliance across projects.
Managing and escalating risks in complex or novel situations, particularly in projects that may involve new technologies or methodologies.
Providing expert programming guidance and support to project teams, influencing stakeholders on programming-related issues.
Ensuring compliance with industry standards and regulatory requirements, and promoting the use of automation tools in the programming workflow.
Managing drug or technical projects using proven project management practices, ensuring timely delivery and quality results.
Contributing to capacity management for all projects within scope, optimizing resource allocation to meet project demands.
Maintaining expertise in the latest industry, regulatory, and technical requirements to ensure programming activities are up-to-date and compliant.

Qualifications and Experience:

Bachelor’s degree in Computer Science (CS), Statistics, Mathematics, or related scientific field.
8+ years of SAS programming experience, with 4+ years of experience in Cardiovascular, Renal, and Metabolism (CVRM) clinical trials.
In-depth experience with CDISC standards (SDTM, ADaM) and an understanding of their application in clinical trials.
Working knowledge of ICH and Good Clinical Practices (GCP), clinical research processes, and related regulatory requirements.
Strong understanding of the clinical drug development process and experience with late-phase studies.
Excellent communication and coordination skills, with the ability to interact with global teams and stakeholders independently.
Proficient in risk management for complex or novel situations, demonstrating the ability to proactively address challenges.
Proven ability to influence relevant stakeholders, ensuring effective decision-making on programming-related matters.
Experience with programming leadership in cross-functional teams, driving project success and providing mentorship to junior staff.

Specific Role Requirements and Skills:

Extensive experience with CVRM clinical trials and protocols, with a focus on driving programming activities in this therapeutic area.
Experience in late-phase studies, with the ability to take full ownership of complex datasets, TLFs (Tables, Listings, Figures), and statistical deliverables.
Strong time management and communication skills, with experience in managing concurrent activities and leading project teams to successful outcomes.
Familiarity with CDISC standards and their application in clinical trial data.
Ability to lead and mentor junior programming staff, contributing to the development of talent within the organization.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

","ClinChoice is seeking a Principal Statistical Programmer to lead the full scope of programming delivery for projects or technical initiatives within the Cardiovascular, Renal, and Metabolism (CVRM) therapeutic area. The ideal candidate will have 8+ years of SAS programming experience, with 4+ years in CVRM clinical trials, and excellent communication and coordination skills. They will be responsible for ensuring high-quality deliverables, driving continuous improvement within the programming discipline, and managing drug or technical projects using proven project management practices. ClinChoice offers a supportive culture, flexible remote work options, and competitive compensation.","Lead statistical programming activities in CVRM clinical trials with ClinChoice, a global full-service CRO. Drive quality deliverables, improve processes, and manage complex projects.",[],"https://boards.greenhouse.io/clinchoice/jobs/4540165101?utm_source=remoteliz.com","2025-02-26T05:06:14.130353-05:00","0000-12-31T19:03:58-04:56",{"_855":2144,"_2041":2042,"_2043":2145,"_2045":89,"_2046":2146,"_2054":2147,"_13":2149,"_2062":2063,"_2064":2151,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2152,"_2086":2153,"_2088":2154,"_2090":2155,"_2092":2156,"_2098":2157,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2158,"_2105":2142},12224,"Clinical Project Manager II",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2148],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2150],{"_16":625,"_18":626,"_20":627,"_22":-5,"_23":628,"_25":629,"_27":630,"_29":631,"_31":-5},"2025-02-24T09:56:58.716349-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Clinical Project Manager II to join our in-house team in France. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As a Clinical Project Manager II you will have proven experience working on Oncology or Respiratory studies, and will be responsible for study execution, tracking and management of study delivery including oversight of vendor and CRO activity. Previous experience working with a CRO and managing complex clinical trials required.

Join our global team and help create a healthier world!

Main Job Tasks and Responsibilities:

Organizes and participates in Monitor’s and Investigator’s Meetings.
Performs, if necessary, co-monitoring visits for the assigned clinical projects.
Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
May act as Feasibility Associate (FEA) after appropriate and documented training.
Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
Regularly track all expenditure and review for consistency with trial budgets.
Organize quality check of filing of key study documentation.
Ensure all administrative close-out procedures are completed.
Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
Proven Project Management experience in the CRO/Pharmaceutical industry, in addition previous experience as CM/CRA in a CRO/Pharmaceutical industry.
Experience working on Oncology or Respiratory studies.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Experience managing oncology and/or respiratory required.
Excellent English communication skills: written and verbal.
Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
Ability to travel as required.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

Key words: Project Manager, Clinical Project Manager, Study Manager, Project Management Associate, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Regional Trial Leader, complex clinical trials, respiratory, oncology, CRO, Contract Research Organization

#LI-CM1 #LI-REMOTE #LI-Intermediate #LI-FULLTIME

","ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance. They are recruiting for a Clinical Project Manager II to join their in-house team in France. The successful candidate will have proven experience working on Oncology or Respiratory studies, managing complex clinical trials, and collaborating with a talented team. As a Clinical Project Manager II, you will be responsible for study execution, tracking, and management of study delivery, including oversight of vendor and CRO activity. You will also develop and implement alternative solutions to problems with study timelines, resources, budgets, etc. ClinChoice offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company. If you are a seasoned founder or an early tinkerer with AI, you will thrive in this role. Apply now and help create a healthier world!","Clinical Project Manager II at ClinChoice: Manage complex clinical trials, collaborate with a talented team, and develop alternative solutions to problems.",[],"https://boards.greenhouse.io/clinchoice/jobs/4539966101?utm_source=remoteliz.com","2025-02-24T09:56:58.718978-05:00",{"_855":2160,"_2041":2042,"_2043":2161,"_2045":89,"_2046":2162,"_2054":2163,"_13":2165,"_2062":2063,"_2064":2167,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2168,"_2086":2169,"_2088":2170,"_2090":2171,"_2092":2172,"_2098":2173,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2174,"_2105":2142},11792,"Principal Statistician– Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2164],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2166],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-21T13:35:58.380782-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

We are currently recruiting for a Principal Statistician to join our growing Late Phase Clinical - Cardiovascular, Renal, and Metabolism (CVRM) portfolio. As a senior member of the team, you will take a leadership role in driving statistical thinking and shaping strategy across complex clinical development programs.

Responsibilities

Lead statistical thinking within cross-functional teams, contributing significantly to early clinical development in the CVRM area.
Drive strategic planning and quantitative decision-making across drug development programs, ensuring robust statistical methodology is applied throughout.
Oversee delivery of statistical support on drug projects and studies, ensuring high quality, timeliness, and adherence to standards, collaborating with CROs and Programming teams as needed.
Lead methodological innovation by adapting or developing new statistical methodologies for early clinical trials, advancing the field through creative solutions.
Develop and implement new procedures and standards aimed at increasing efficiency, quality, and effectiveness across clinical development.

Acting as a subject matter expert in statistical methodologies, liaising with external collaborators and regulatory agencies.
Mentoring junior staff and fostering the development of talent by providing guidance, training, and support in statistical techniques.
Engaging with regulatory agencies, participating in meetings, and addressing statistical queries during regulatory submissions.

Qualification

MSc/PhD in Statistics or Mathematics (with a strong statistical focus) and significant experience in pharmaceutical/healthcare statistics or related fields.
Proven leadership capabilities to direct cross-functional teams and manage complex projects.
Extensive experience in data analysis and statistical interpretation in clinical trials, with a deep understanding of regulatory and technical requirements.
High proficiency in statistical programming (e.g., R and/or SAS), with a track record of applying these skills in drug development.
Strong collaboration skills, with the energy to work across global, cross-functional teams and external partners.
Experience in program and study design for clinical trials, particularly in early-stage clinical development.
Knowledge or experience in the Cardiovascular, Renal, and Metabolism (CVRM) therapeutic areas.
Experience with regulatory interactions, including presenting statistical findings and answering queries from regulatory bodies.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

","ClinChoice is seeking a Principal Statistician to join their Late Phase Clinical - Cardiovascular, Renal, and Metabolism (CVRM) portfolio. The ideal candidate will lead statistical thinking within cross-functional teams, drive strategic planning, and oversee delivery of statistical support on drug projects. They should have significant experience in pharmaceutical/healthcare statistics, data analysis, and regulatory interactions. ClinChoice offers a supportive culture, professional development opportunities, and flexible remote work options.","Principal Statistician for Late Phase Clinical - Cardiovascular, Renal, and Metabolism (CVRM) portfolio at ClinChoice",[],"https://boards.greenhouse.io/clinchoice/jobs/4540191101?utm_source=remoteliz.com","2025-02-21T13:35:58.383739-05:00",{"_855":2176,"_2041":2042,"_2043":2177,"_2045":89,"_2046":2178,"_2054":2179,"_13":2181,"_2062":2063,"_2064":2183,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2184,"_2086":2185,"_2088":2186,"_2090":2187,"_2092":2188,"_2098":2189,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2190,"_2105":2142},11793,"Medical Information Call Center Consultant (MICC Consultant)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2180],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2182],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-21T13:34:57.444-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Medical Information Call Center Consultant (MICC Consultant) to join one of our clients.

Main Job Tasks and Responsibilities:

Medical Knowledge:

Proficiency: Strong understanding and competence in medical and therapeutic terminology. Ability to accurately interpret and communicate complex medical information to both healthcare professionals and patients.
Narrative Skills: Exceptional narrative writing skills for documenting inquiries and responses clearly and concisely, ensuring compliance with regulatory requirements.

Customer Handling Skills:

Communication: Excellent verbal communication skills with a neutral accent to ensure clear understanding across diverse demographics.
Empathy: Ability to exhibit empathy and patience, especially when dealing with distressed or difficult customers. Skilled in de-escalation techniques and maintaining a professional demeanor.
Problem-Solving: Strong problem-solving abilities to address customer inquiries effectively and efficiently, providing accurate and helpful information

Regulatory Compliance:

Patient Safety: Comprehensive understanding of patient safety protocols and the importance of accurate information dissemination.
Regulatory Knowledge: Familiarity with local and international regulatory obligations, such as FDA, EMA, and other relevant authorities. Ability to adhere to guidelines and ensure compliance in all interactions.

Documentation: Proficiency in maintaining detailed and accurate records of all customer interactions, ensuring traceability and accountability.

Education and Experience:

Minimum Requirement of bachelor’s degree in Biosciences (e.g., Biology, Biochemistry, Biotechnology) or a professional healthcare qualification (e.g., B. Pharm/M.pharm, Nursing, Dentistry)

At least 1 year of PV experience (Candidates with MICC experience is preferred)

Experience in relevant fields, along with certifications in medical information or pharmacovigilance.

The MICC staff will cover EST Hours.

Bilingual is an advantage.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: MICC, PV, Devices, Medical Device

#LI-PB1

","ClinChoice is seeking a Medical Information Call Center Consultant (MICC Consultant) to join one of their clients. The ideal candidate will have strong medical knowledge, excellent communication skills, and the ability to work independently while establishing trust with client counterparts. As a MICC Consultant, you will be responsible for providing accurate information on medical devices, handling customer inquiries, and ensuring regulatory compliance. ClinChoice is a global full-service CRO with a focus on quality, professional development, and supportive culture. The company offers flexible remote work options, competitive salary, and opportunities for growth and development. If you are passionate about delivering high-quality service and have experience in medical information or pharmacovigilance, apply now to join the ClinChoice team.","Medical Information Call Center Consultant (MICC) role at ClinChoice, providing accurate info on medical devices, handling customer inquiries & ensuring regulatory compliance.",[],"https://boards.greenhouse.io/clinchoice/jobs/4540208101?utm_source=remoteliz.com","2025-02-21T13:34:57.448313-05:00",{"_855":2192,"_2041":2042,"_2043":2193,"_2045":89,"_2046":2194,"_2054":2195,"_13":2197,"_2062":2063,"_2064":2199,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2200,"_2086":2201,"_2088":2202,"_2090":2203,"_2092":2204,"_2098":2205,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2206,"_2105":2142},11680,"Clinical Data Management Lead Consultant - (AD/DIR Level)(REMOTE - Long Term Contract)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2196],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2198],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-20T15:38:16.956272-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Data Management Lead Consultant to join one of our clients in Hematology TA Team.

Job Summary:

The Head of Data Management will take a proactive role in overseeing and executing end-to-end clinical data management processes. This role requires both technical expertise and strategic leadership, ensuring high-quality data collection, processing, and reporting in compliance with global regulatory standards (FDA, EMA, ICH-GCP, CDISC).

Key Responsibilities:

Hands-On Clinical Data Management & Execution:

Actively design, build, and maintain clinical trial databases using industry-leading EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault).
Perform data validation, query management, and cleaning to ensure data accuracy and completeness.
Oversee the data review process, working closely with study teams to resolve discrepancies.
Ensure timely database lock and submission-ready datasets in alignment with CDISC standards (SDTM, ADaM).
Implement and optimize data integration, automation, and reporting solutions.

Leadership & Strategic Oversight:

Lead and mentor a team of Clinical Data Managers while remaining involved in hands-on data management activities.
Develop and implement data management SOPs, policies, and best practices.
Serve as the primary liaison between data management, biostatistics, clinical operations, and regulatory affairs.
Evaluate and implement cutting-edge technologies for AI-driven automation and data analytics in clinical trials.

Regulatory Compliance & Quality Assurance:

Ensure compliance with FDA, EMA, ICH-GCP, GDPR, and 21 CFR Part 11 regulatory guidelines.
Lead regulatory audits and inspections related to clinical data management.
Drive the adoption of risk-based monitoring approaches for efficient data quality oversight.

Qualifications & Experience:

Master’s or Bachelor’s degree in Life Sciences, Computer Science, Biostatistics, or a related field.
Minimum 10+ years in Clinical Data Management, with at least 5 years in a hands-on leadership role.
Proven experience working with EDC systems (Medidata Rave, Oracle Clinical, Veeva Vault, etc.).
Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
Proficiency in SQL, SAS, R, Python, or other data analysis tools is a plus.
Ability to balance hands-on execution with leadership responsibilities.
Strong problem-solving skills and attention to detail.
Excellent communication and cross-functional collaboration skills.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

","We are seeking a Clinical Data Management Lead Consultant to join one of our clients in Hematology TA Team. The ideal candidate will have 10+ years of experience in Clinical Data Management, with at least 5 years in a hands-on leadership role. They should be proficient in EDC systems, CDISC standards, and regulatory submission requirements. The consultant will oversee end-to-end clinical data management processes, lead a team, and ensure compliance with global regulatory standards. They will also implement cutting-edge technologies for AI-driven automation and data analytics in clinical trials. With a strong focus on quality, professional development, and supportive culture, ClinChoice offers a unique opportunity to work directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring.","Clinical Data Management Lead Consultant - Join our team and lead end-to-end clinical data management processes with expertise in EDC systems, CDISC standards, and regulatory submission requirements.",[],"https://boards.greenhouse.io/clinchoice/jobs/4539621101?utm_source=remoteliz.com","2025-02-20T15:38:16.959031-05:00",{"_855":2208,"_2041":2042,"_2043":2209,"_2045":89,"_2046":2210,"_2054":2211,"_13":2213,"_2062":2063,"_2064":2241,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2242,"_2086":2243,"_2088":2244,"_2090":2245,"_2092":2246,"_2098":2247,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2248,"_2105":2142},11660,"Senior Statistician Consultant- Late Phase Oncology (Remote in EU/UK)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2212],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2214,2215,2216,2217,2218,2219,2220,2221,2222,2223,2224,2225,2226,2227,2228,2229,2230,2231,2232,2233,2234,2235,2236,2237,2238,2239,2240],{"_16":465,"_18":466,"_20":467,"_22":-5,"_23":468,"_25":469,"_27":470,"_29":471,"_31":-5},{"_16":505,"_18":506,"_20":507,"_22":-5,"_23":508,"_25":509,"_27":510,"_29":511,"_31":-5},{"_16":577,"_18":578,"_20":579,"_22":-5,"_23":580,"_25":581,"_27":582,"_29":583,"_31":-5},{"_16":617,"_18":618,"_20":619,"_22":-5,"_23":620,"_25":621,"_27":622,"_29":623,"_31":-5},{"_16":625,"_18":626,"_20":627,"_22":-5,"_23":628,"_25":629,"_27":630,"_29":631,"_31":-5},{"_16":681,"_18":682,"_20":683,"_22":-5,"_23":684,"_25":685,"_27":686,"_29":687,"_31":-5},{"_16":705,"_18":706,"_20":707,"_22":-5,"_23":708,"_25":709,"_27":710,"_29":711,"_31":-5},{"_16":1113,"_18":1114,"_20":1115,"_22":-5,"_23":1116,"_25":1117,"_27":1118,"_29":1119,"_31":-5},{"_16":145,"_18":146,"_20":147,"_22":-5,"_23":148,"_25":149,"_27":150,"_29":151,"_31":-5},{"_16":201,"_18":202,"_20":203,"_22":-5,"_23":204,"_25":205,"_27":206,"_29":207,"_31":-5},{"_16":305,"_18":306,"_20":307,"_22":-5,"_23":308,"_25":309,"_27":310,"_29":311,"_31":-5},{"_16":481,"_18":482,"_20":483,"_22":-5,"_23":484,"_25":485,"_27":486,"_29":487,"_31":-5},{"_16":1729,"_18":1730,"_20":1731,"_22":-5,"_23":1732,"_25":1733,"_27":1734,"_29":1735,"_31":-5},{"_16":1625,"_18":1626,"_20":1627,"_22":-5,"_23":1628,"_25":1629,"_27":1630,"_29":1631,"_31":-5},{"_16":1633,"_18":1634,"_20":1635,"_22":-5,"_23":1636,"_25":1637,"_27":1638,"_29":1639,"_31":-5},{"_16":993,"_18":994,"_20":995,"_22":-5,"_23":996,"_25":997,"_27":998,"_29":999,"_31":-5},{"_16":1041,"_18":1042,"_20":1043,"_22":-5,"_23":1044,"_25":1045,"_27":1046,"_29":1047,"_31":-5},{"_16":1049,"_18":1050,"_20":1051,"_22":-5,"_23":1052,"_25":1053,"_27":1054,"_29":1055,"_31":-5},{"_16":1265,"_18":1266,"_20":1267,"_22":-5,"_23":1268,"_25":1269,"_27":1270,"_29":1271,"_31":-5},{"_16":1433,"_18":1434,"_20":1435,"_22":-5,"_23":1436,"_25":1437,"_27":1438,"_29":1439,"_31":-5},{"_16":1465,"_18":1466,"_20":1467,"_22":-5,"_23":1468,"_25":1469,"_27":1470,"_29":1471,"_31":-5},{"_16":1681,"_18":1682,"_20":1683,"_22":-5,"_23":1684,"_25":1685,"_27":1686,"_29":1687,"_31":-5},{"_16":489,"_18":490,"_20":491,"_22":-5,"_23":492,"_25":493,"_27":494,"_29":495,"_31":-5},{"_16":1441,"_18":1442,"_20":1443,"_22":-5,"_23":1444,"_25":1445,"_27":1446,"_29":1447,"_31":-5},{"_16":825,"_18":826,"_20":827,"_22":-5,"_23":828,"_25":829,"_27":830,"_29":831,"_31":-5},{"_16":873,"_18":874,"_20":875,"_22":-5,"_23":876,"_25":877,"_27":878,"_29":879,"_31":-5},{"_16":897,"_18":898,"_20":899,"_22":-5,"_23":900,"_25":901,"_27":902,"_29":903,"_31":-5},"2025-02-20T13:02:08.81898-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Senior Statistician Consultant- Onco Late Phase to join one of our clients.

Main Job Tasks and Responsibilities:

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for validity of analysis and explore alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Education and Experience:

MS or PhD in Statistics, Biostatistics or related field. PhD with 2-4 years of experience or MS with 4-6 years of experience.
Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-TT1 #LI-Remote #Senior #Contract

","ClinChoice is seeking a Senior Statistician Consultant for late-phase oncology studies. The ideal candidate will have extensive experience in statistical analysis, protocol development, and data management. They should be able to work independently and establish high-trust relationships with clients. As a global CRO, ClinChoice offers a supportive culture, professional development opportunities, and flexible remote work options. The role involves mentoring peers, managing projects, and ensuring quality and consistency in statistical analyses. With over 28 years of experience in clinical development, ClinChoice is committed to contributing to a healthier world by accelerating the development and commercialization of innovative drugs and devices.","Senior Statistician Consultant for late-phase oncology studies with extensive experience in statistical analysis, protocol development, and data management.",[],"https://boards.greenhouse.io/clinchoice/jobs/4539532101?utm_source=remoteliz.com","2025-02-20T13:02:08.822117-05:00",{"_855":2250,"_2041":2042,"_2043":2251,"_2045":89,"_2046":2252,"_2054":2253,"_13":2255,"_2062":2063,"_2064":2257,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2258,"_2086":2259,"_2088":2260,"_2090":2261,"_2092":2262,"_2098":2263,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2264,"_2105":2142},11477,"Safety Medical Reviewer Consultant",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2254],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2256],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-19T17:47:28.114279-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Safety Medical Reviewer Consultant to join one of our clients.

Main Job Tasks and Responsibilities:

Identify, review and evaluate individual case safety reports (ICSRs) including SAEs and SUSARs for completeness, accuracy, consistency, and overall medical content.
Perform medical review of adverse event reports (SAEs and SUSARs), including expectedness/listedness, seriousness, and causality assessments.
Ensure timely completion of medical reviews and assessment to meet internal and regulatory requirements.
Prepare and draft case queries based on medical review of ICSRs, as appropriate. Track follow-up requests and interactions with healthcare professionals, investigators, or other stakeholders regarding adverse event information.
Provide support and review for medical coding issues/discrepancies.
Review of Line Listing of cases to evaluate the MedDRA coding and other applicable coding system as necessary.
Escalates in a timely manner any potential safety issues or signals to the appropriate stakeholders.
Develop and provide training related to medical review (ICSR, Aggregate Reports, or Signal Detection) for new hires and junior team members. Keep team’s knowledge up-to-date, based on the latest regulations and company conventions related to medical reviews.
Based on requirement, may support in medical and scientific discussions with internal and external stakeholders.
Collaborate with aggregate report medical writer and physicians to write and review RMPs, aggregate reports (PSURs/PBRERs/PADERs/DSURs, IND Annual Reports, and other ad-hoc reports).
Review and provide safety therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents, as assigned.
Generate, review, and update follow-up queries for the prescribers and investigators, as assigned.
Support signal detection activities by providing medical insights and identifying potential trends in safety data.
Assist in writing and/or reviewing of monthly safety signal reports.
Provide expert input on adverse event reports for regulatory and safety reporting.
Participate in risk management and mitigation strategies in collaboration with safety and medical teams.
Participate and support in internal and regulatory audit and inspections, as required.
Work closely with the safety team, regulatory affairs, clinical development, and medical affairs to ensure alignment of safety data and compliance with regulatory guidelines.
Provide medical expertise to help resolve complex safety issues or cases that require further clarification or follow-up.

Education and Experience:

Medical Doctor, MD
Excellent medical judgment and ability to assess causality and seriousness of adverse events.
Attention to detail and accuracy in data review and reporting.
Strong communication and collaboration skills for working with cross-functional teams.
Ability to work in a fast-paced environment and manage multiple tasks with deadlines.

Specific Role Requirements and Skills:

Strong understanding of safety regulations and guidelines (e.g., ICH, FDA, EMA).
Experience in medical review for ICSRs and Signal Detection activities.
Proficiency in MS Office and safety databases (e.g., Argus, Veeva Vault).

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Medical Reviewer, Oncology, ICSRs and Signal Detection activities.

#LI-PB1

","ClinChoice is seeking a Safety Medical Reviewer Consultant to join one of their clients. The role involves reviewing and evaluating individual case safety reports (ICSRs) for completeness, accuracy, consistency, and medical content. The consultant will also perform medical reviews of adverse event reports, prepare and draft case queries, and provide support and training related to medical review. The ideal candidate has a strong understanding of safety regulations and guidelines, excellent medical judgment, attention to detail, and strong communication skills. ClinChoice is a global full-service CRO with a supportive culture and flexible remote work options.","Safety Medical Reviewer Consultant job at ClinChoice, reviewing ICSRs and adverse event reports, providing training and support.",[],"https://boards.greenhouse.io/clinchoice/jobs/4538957101?utm_source=remoteliz.com","2025-02-19T17:47:28.116236-05:00",{"_855":2266,"_2041":2042,"_2043":2267,"_2045":89,"_2046":2268,"_2054":2269,"_13":2271,"_2062":2063,"_2064":2273,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2274,"_2086":2275,"_2088":2276,"_2090":2277,"_2092":2278,"_2098":2279,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2280,"_2105":2142},11461,"Senior Clinical Research Associate - Oncology/Respiratory",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2270],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2272],{"_16":897,"_18":898,"_20":899,"_22":-5,"_23":900,"_25":901,"_27":902,"_29":903,"_31":-5},"2025-02-19T15:27:31.530887-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for two dynamic professionals to join our in-house team as a Senior Clinical Research Associate (Senior CRA) on a permanent basis. You will be working on 2-3 trials, where you will be responsible for site management (including start-up), both on-site and remotely, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Previous experience monitoring oncology and/or respiratory clinical trials is required.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
May act as Feasibility Associate.
Train site staff in all study procedures.
Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
Act as the main contact person for the site in order to ensure close follow up.
Provide general support to the Clinical Research Division on quality control of clinical data.
Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.
Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
Develop training material and give training in collaboration with the Training & Qualification Management Unit.
May assist with contract negotiation with sites on study budget after appropriate training.
Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.
May support the submission process in the project including submission requirements, timelines, informed consent development, etc..
Guide and supervise Clinical Research Associate I (CRA I) in order to coach and train them on the job.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
Proven experience as a CRA, performing on-site monitoring activities.
Experience with oncology or respiratory trials is required.
Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Associate, CRA, Site Management, Site Manager, Monitor, Monitoring, Oncology, Rare Disease, Rheumatology, Respiratory, Travel, Submissions, Ethics, CRO, Contract Research Organisation

#LI-CM1 #LI-Remote

","ClinChoice is a global full-service CRO seeking two dynamic professionals to join their in-house team as Senior Clinical Research Associates (Senior CRA) on a permanent basis. The ideal candidate will have previous experience monitoring oncology and/or respiratory clinical trials, strong knowledge of clinical trial operations, GCP/ICH Guidelines, and regulatory requirements. As a Senior CRA, you will be responsible for site management, including start-up, both on-site and remotely, while working on projects from various client bases. You will also assist in the selection of sites, train site staff, conduct monitoring visits, and manage investigational products. ClinChoice offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company. Join their team to make a difference in people's lives and experience a fulfilling career.","Join ClinChoice as a Senior Clinical Research Associate (Senior CRA) and contribute to the development of innovative drugs and devices. With flexible remote work options and $4,000/year travel stipends, you'll have the opportunity to make a meaningful impact on global healthcare.",[],"https://boards.greenhouse.io/clinchoice/jobs/4528698101?utm_source=remoteliz.com","2025-02-19T15:27:31.533501-05:00",{"_855":2282,"_2041":2042,"_2043":2283,"_2045":89,"_2046":2284,"_2054":2285,"_13":2287,"_2062":2063,"_2064":2289,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2290,"_2086":2291,"_2088":2292,"_2090":2293,"_2092":2294,"_2098":2295,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2296,"_2105":2142},10186,"Clinical Trial Administrator",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2286],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2288],{"_16":201,"_18":202,"_20":203,"_22":-5,"_23":204,"_25":205,"_27":206,"_29":207,"_31":-5},"2025-02-14T14:39:57.874318-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice, is searching for a Clinical Trial Admnistrator to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines where you will work in a Hybrid model, 1.0 FTE, temporary contract.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

In this role you will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization. Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required. Supports project managers within the assigned clinical studies.

Main Job Tasks and Responsibilities:

Clinical Administration Tasks - (includes (one) CTMS build and tracking, v-TMF build & upload).
Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
Creation/distribution of regulatory binders & the wet-ink signed documents binder.
Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
Assist in providing internal communication of important clinical data and events.
Support ongoing use of (one)CTMS by maintaining and tracking relevant activities.
Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs.
May be asked to assist with Device tracking and ordering if required and if applicable.
Assistance with logistics for Investigator meetings/expert panel meetings.
Assistance with distribution of newsletter (create mailing list from (one)CTMS and routing for internal approval).
Participates in process improvement activities related to (one) CTMS/vTMF within the department.
May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders.
Education and Experience:

Minimum of a Bachelor’s Degree is required.
Previous clinical research experience a plus.
Requires previous administrative support experience or equivalent for at least 1 year.
Clinical/medical background a plus.
Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).
Demonstrated competencies in the following areas are required: Tracking; Written and verbal communications; Attention to details and organizational skills.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Keywords: Clinical Trial Administrator, Clinical Trial, ICH-GCP, Regulatory, Medical Devices, Contract Research Organisation, CRO.

#LI-CM1 #LI-Temporary

","ClinChoice, a global full-service CRO, is seeking a Clinical Trial Administrator to join one of their partner companies. The role involves providing support to clinical study staff, managing trial master files, and fostering strong relationships with colleagues. As a client-facing role, the candidate must be confident, able to work independently, and establish high-trust environments. The ideal candidate has a minimum Bachelor's Degree, previous clinical research experience, and administrative support experience. They should also have knowledge of computer systems and demonstrated competencies in tracking, written and verbal communications, attention to details, and organizational skills. ClinChoice offers flexible remote work options, competitive salary, and opportunities for professional development.","Clinical Trial Administrator at ClinChoice: Manage trial master files, foster strong relationships with colleagues, and provide administrative support to clinical study staff.",[],"https://boards.greenhouse.io/clinchoice/jobs/4533343101?utm_source=remoteliz.com","2025-02-14T14:39:57.876058-05:00",{"_855":2298,"_2041":2042,"_2043":2299,"_2045":89,"_2046":2300,"_2054":2301,"_13":2303,"_2062":2063,"_2064":2305,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2306,"_2086":2307,"_2088":2308,"_2090":2309,"_2092":2310,"_2098":2311,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2312,"_2105":2142},10230,"Clinical Project Director",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2302],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2304],{"_16":897,"_18":898,"_20":899,"_22":-5,"_23":900,"_25":901,"_27":902,"_29":903,"_31":-5},"2025-02-14T14:35:56.880161-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice, is searching for an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners, to oversee Clinical Project Leaders who are in charge of clinical studies. This can be a home based position, with occasional visits to the office. It will initially be a Fixed Term Contract until the end of December 2025 to cover maternity leave.

Main Job Tasks and Responsibilities:

Oversight and operational management of clinical Trials from study design until study close-out, ensuring on time and on budget completion, with adherence to the required quality standards and compliance with ICH, GCP and Company's Standard Operating Procedures (SOPs).
Design and development of full synopsis and protocol by leading cross-functional team members.
Management of the CRO by acting as primary contact, managing day-to-day relationships, raising issues as soon as they are identified.
Management of study budget, scope changes and financial reconciliation.
Preparation and coordination of scientific meetings incl. KOLs meeting, Investigators’ meeting, blinded review meeting.
Preparation, review and approval of Clinical Study Report (CSR) in cooperation with the Medical Writer and other required key team stakeholders.
Reporting to Company's senior management.
Operational management coordination of assigned projects.
Clinical Development Plan (CDP) definition in relation to studies’ operational aspects.
Interactions with all functions supporting the Clinical Development Plan.
Line Management of Clinical Project Managers (CPMs).
Oversight of CPMs involved in different trials of assigned programs.

Education, Experience and Skills:

University Degree in scientific, pharmacy or other health related discipline, or equivalent.
Proven experience as Clinical Project Manager.
Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Knowledge of planning tools and planning principles.
Knowledge of GLP for bio analytical assays.
Knowledge of Trial Master File.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Project Manager, Clinical Project Director, CPM, CPD, Respiratory, Freelance, Permanent, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

#LI-DPN

","ClinChoice is seeking an experienced Senior Project Manager/Director to oversee clinical studies for a pharmaceutical partner. The ideal candidate will have a strong background in clinical trial operations, GCP/ICH guidelines, and project management. They will be responsible for managing study budgets, coordinating scientific meetings, and ensuring on-time completion of trials. ClinChoice offers a supportive culture, professional development opportunities, and competitive compensation. This is a fixed-term contract until December 2025, with occasional visits to the office and flexible remote work options.","Senior Project Manager/Director for clinical studies at ClinChoice, managing study budgets and coordinating scientific meetings.",[],"https://boards.greenhouse.io/clinchoice/jobs/4398976101?utm_source=remoteliz.com","2025-02-14T14:35:56.881919-05:00",{"_855":2314,"_2041":2042,"_2043":2315,"_2045":89,"_2046":2316,"_2054":2317,"_13":2319,"_2062":2063,"_2064":2321,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2322,"_2086":2323,"_2088":2324,"_2090":2325,"_2092":2326,"_2098":2327,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2328,"_2105":2142},10343,"Project Director, Clinical Operations - Respiratory",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2318],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2320],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T13:09:45.978998-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

The Project Director, Clinical Operations is responsible for the accountability for the accountability of the assigned clinical projects in order to ensure that clinical projects are delivered on time, within budget and with the required quality standards. Applicants must have a strong background with Respiratory trials.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
Manage the projects at a global level and ensure consistent and continuous focus to Client’s specifications and satisfaction.
Meet and exceed the project’s deliverables: timelines, budget and quality.
Set project plans, monitor the adherence to the plans, proactively addresses with Project Leader/Project Director and his/her team any risk of variations.
Plan and manage the Project Boards for the assigned projects and agrees with the Global Head the project needs.
Responsible for the identification, resolution and escalation of any issues.
Achieve the Project KPIs, understand performance issues, share best practices and lessons learnt.
Define, plan and manage internal and external communications on the assigned projects planning and status.
Serve as a source of scientific and therapeutical expertise.
Give scientific and operational input to proposal development and contribute to the preparation of the strategic documents and bid defense meetings.
May act as Program Director for existing and potential new projects.
May participate in Monitor’s and Investigator’s Meeting.
Give input to the Clinical Research Operations Department Senior Director for periodic performance assessment on the basis of projects management experience.
Monitor and enforce compliance with ClinChoice systems, processes, policies and all applicable regulations.
Participate in review/design of processes and SOPs providing input based on projects management experience.
Maintain relationships with the Sponsors.

Education, Experience and Skills

University Degree in scientific and/or medical disciplines.
Eight years (at least) of Clinical Research experience in the CRO/Pharmaceutical industry and after gaining excellent knowledge in developing work organization models.
Strong knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Department Director, Clinical Research Director, Clinical Director, Oncology, Respiratory, Bid Defense, CRO, Contract Research Organisation

#LI-DNP

","ClinChoice is seeking a Project Director, Clinical Operations - Respiratory to join their team in Horsham, PA. The ideal candidate will have 8+ years of experience in clinical research, strong knowledge of GCP-ICH guidelines, and excellent project management skills. They will be responsible for ensuring projects are delivered on time, within budget, and with required quality standards. ClinChoice offers a fulfilling career, flexible remote work options, and opportunities to contribute to global healthcare. The company values diversity and inclusivity, and is an equal opportunity employer.","Join ClinChoice as Project Director, Clinical Operations - Respiratory and contribute to accelerating the development and commercialization of innovative drugs and devices.",[],"https://boards.greenhouse.io/clinchoice/jobs/4528194101?utm_source=remoteliz.com","2025-02-14T13:09:45.980992-05:00",{"_855":2330,"_2041":2042,"_2043":2331,"_2045":89,"_2046":2332,"_2054":2333,"_13":2335,"_2062":2063,"_2064":2337,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2338,"_2086":2339,"_2088":2340,"_2090":2341,"_2092":2342,"_2098":2343,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2344,"_2105":2142},10275,"Executive-Medical Device Technical Writing Consultant",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2334],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2336],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T12:54:42.195084-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Executive-Medical Device Technical Writing Consultant to join one of our clients.

Main Job Tasks and Responsibilities:

Plan and execute general technical writing activities with minimal or no support or guidance and support senior members with project and management activities.
Ensure assigned technical writing documents (including but not limited to, Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Summary of Safety and Clinical Performance (SSCP) and State of the Art (SOA) are compliant with client procedures, regulatory requirements, and client guidelines
Ensure efficient management of timeline and aim to increase productivity
Familiar with industry standards, clinical practice guidelines, safety reporting, and MDR regulations/specifications.
Ensure documents are compliant with client procedures, regulatory requirements, and client guidelines
Ensure error-free and acceptable quality in assigned deliverables.
Alert and escalate to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.
Contribute towards the achievement of Quality Objectives.
Responsible for end-to-end ownership of the document
Responsible for ensuring training compliance and timesheet compliance.

Education and Experience:

Thorough understanding of regulatory documents such as MEDDEV 2.7/1 Rev 4, MDR regulations and associated regulatory guidelines.
Excellent written and verbal communication skills.
Attention to detail and ability to multitask.
Possesses logical, analytical and verbal skills
Bachelor’s Degree in Life Sciences or above and in alignment with project/business team requirements.
Minimum of 2 to 4 years of relevant experience in identified functional domain/ business work stream

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Medical Writing, Medical Device, MDD, MDR Regulations, CER

#LI-PB1

","ClinChoice is seeking an Executive-Medical Device Technical Writing Consultant to join one of their clients. The ideal candidate will have a thorough understanding of regulatory documents such as MEDDEV 2.7/1 Rev 4, MDR regulations, and excellent written and verbal communication skills. They will be responsible for planning and executing general technical writing activities, ensuring compliance with client procedures and regulatory requirements, and contributing to the achievement of Quality Objectives. The role requires attention to detail, analytical skills, and ability to multitask. ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They offer a supportive culture, continuous training, and opportunities for career growth. As a client-facing role, the consultant will work independently while establishing high-trust relationships with clients. The position is based in the United States and offers flexible remote work options.","Medical Device Technical Writing Consultant job at ClinChoice: Ensure compliance with regulatory requirements and contribute to quality objectives.",[],"https://boards.greenhouse.io/clinchoice/jobs/4429821101?utm_source=remoteliz.com","2025-02-14T12:54:42.196868-05:00",{"_855":2346,"_2041":2042,"_2043":2145,"_2045":89,"_2046":2347,"_2054":2348,"_13":2350,"_2062":2063,"_2064":2352,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2353,"_2086":2354,"_2088":2355,"_2090":2356,"_2092":2357,"_2098":2358,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2359,"_2105":2142},10375,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2349],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2351],{"_16":1897,"_18":1898,"_20":1899,"_22":-5,"_23":1900,"_25":1901,"_27":1902,"_29":1903,"_31":-5},"2025-02-14T12:26:07.643418-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Clinical Project Manager II to join our in-house team in the UK. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Join our global team and help create a healthier world!

Main Job Tasks and Responsibilities:

Organizes and participates in Monitor’s and Investigator’s Meetings.
Performs, if necessary, co-monitoring visits for the assigned clinical projects.
Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
May act as Feasibility Associate (FEA) after appropriate and documented training.
Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
Regularly track all expenditure and review for consistency with trial budgets.
Organize quality check of filing of key study documentation.
Ensure all administrative close-out procedures are completed.
Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
Proven Project Management experience in the CRO/Pharmaceutical industry, in addition previous experience as CM/CRA in a CRO/Pharmaceutical industry.
Experience working on Oncology or Respiratory studies.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Experience managing oncology and/or respiratory required.
Excellent English communication skills: written and verbal.
Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
Ability to travel as required.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

#LI-LG1 #LI-Intermediate #LI-FULLTIME

","ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance. They are recruiting for a Clinical Project Manager II to join their in-house team in the UK. The successful candidate will have proven experience working on Oncology or Respiratory studies, managing complex clinical trials, and collaborating with a talented team. As a Clinical Project Manager II, you will be responsible for study execution, tracking, and management of study delivery, including oversight of vendor and CRO activity. You will also develop and implement alternative solutions to problems with study timelines, resources, budgets, etc. ClinChoice offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company. If you are a seasoned founder or an early tinkerer with AI, you will thrive in this role. Apply now and help create a healthier world!","Join ClinChoice as Clinical Project Manager II and contribute to the development of innovative drugs and devices. Manage complex clinical trials, collaborate with a talented team, and develop alternative solutions to problems.",[],"https://boards.greenhouse.io/clinchoice/jobs/4528211101?utm_source=remoteliz.com","2025-02-14T12:26:07.645683-05:00",{"_855":2361,"_2041":2042,"_2043":2362,"_2045":89,"_2046":2363,"_2054":2364,"_13":2366,"_2062":2063,"_2064":2368,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2369,"_2086":2370,"_2088":2371,"_2090":2372,"_2092":2373,"_2098":2374,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2375,"_2105":2142},10361,"Director of Business Development",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2365],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2367],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T12:11:35.753015-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. We are recruiting for a Director of Business Development, who will be responsible for selling pharmacovigilance, medical affairs and regulatory affairs services. Additional tasks include lead generation, opportunity assessment, creating new accounts and growing existing accounts. This is a full-time permanent opportunity. Previous experience working with a global Contract Research Organization and selling pharmacovigilance, medical affairs and regulatory affairs services is required.

Main Job Tasks and Responsibilities:

Identify, assess, and pursue new business opportunities in the area of medical affairs, regulatory affairs and pharmacovigilance services.
Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.
Develop a deep appreciation for the client’s business challenges and organizational structure and use this insight to develop realistic and actionable account plans.
Contribute to the ongoing refinement of the company’s business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.
Work to exceed revenue targets that align with the company's growth objectives.

Education and Experience:

6+ years of sales and account management experience
Previous CRO experience is required.
Experience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory Affairs
Have a network of decision-makers in the life-sciences industry
Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders
Strong negotiation skills with a proven track record of closing complex business deals
Persuasive and compelling presentation and communication skills, both written and verbal
Ability to interpret business challenges and present quick and responsive high-level solutions
Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle
Positive employer and client references
BA, MBA, or equivalent experience

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Keywords: Business development, customer relationship management, business strategy, communications, customer service, sales experience, negotiations, lead generation, cold calling, networking, clinical trials, pharmacovigilance, medical affairs and regulatory affairs

#LI-VH1 #LI-Remote #LI-Senior #LI-FULLTIME

","ClinChoice is a global full-service CRO seeking a Director of Business Development to sell pharmacovigilance, medical affairs, and regulatory affairs services. The ideal candidate has 6+ years of sales and account management experience, previous CRO experience, and expertise in functional and consultancy sales with a focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory Affairs. The Director will build relationships with key decision-makers, develop realistic account plans, and contribute to the company's business development approach. ClinChoice offers a supportive culture, flexible remote work options, and competitive compensation. As part of a global team, the Director will help accelerate the development and commercialization of innovative drugs and devices, contributing to a healthier and safer world. With over 28 years of proven high-quality delivery, ClinChoice is an equal opportunity employer committed to diversity and inclusivity.","Director of Business Development at ClinChoice: Sell pharmacovigilance, medical affairs, and regulatory affairs services to clients worldwide.",[],"https://boards.greenhouse.io/clinchoice/jobs/4527448101?utm_source=remoteliz.com","2025-02-14T12:11:35.755189-05:00",{"_855":2377,"_2041":2042,"_2043":2378,"_2045":89,"_2046":2379,"_2054":2380,"_13":2382,"_2062":2063,"_2064":2384,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2385,"_2086":2386,"_2088":2387,"_2090":2388,"_2092":2389,"_2098":2390,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2391,"_2105":2142},10336,"Senior Regulatory Affairs Specialist Consultant - OTC products",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2381],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2383],{"_16":505,"_18":506,"_20":507,"_22":-5,"_23":508,"_25":509,"_27":510,"_29":511,"_31":-5},"2025-02-14T11:57:33.667988-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice, is searching for an experienced Senior Regulatory Affairs Specialist Consultant (OTC products) with REMOTE option in DENMARK for 12 months contract to work with one of our Consumer Health partners, with a focus on over-the-counter (OTC) Pharmaceuticals.

The Senior Regulatory Affairs Specialist has a thorough understanding of the regulatory environment in Denmark and other Nordic countries, including submission requirements, approval pathways, and compliance activities, with a focus on their impact on business objectives.

They ensure the success of product registrations, line extensions, and new claims in alignment with the business plan. The specialist manages the coordination, compilation, and submission of applications for medicinal products, medical devices, food supplements, and similar products to regulatory agencies. They also maintain compliance with local regulations and quality system requirements for all products.
Main focus is OTC medicinal products

Main Job Tasks and Responsibilities:

KEY RESPONSIBILITIES

Regulatory Strategy
- Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams
- Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
- Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
- Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.

Regulatory Compliance
- Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally
- Ensures that all products comply with local regulatory and quality system requirements.
- Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions
- Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support
- Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
- Ensures that the enterprise Regulatory systems are accurate and fully maintained
- Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
- Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives
- Supports internal and external audits and inspections in collaboration with quality function

SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE

• Relevant Bachelor's Degree or higher
• 6+yrs related regulatory experience
• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Medical Devices and Food Supplements.
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions through the product lifecycle
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Full Proficiency in Danish and English

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Keywords: Regulatory Affairs, Reg Affairs, RA, Over the Counter, OTC, Consumer Health, medicinal products

#LI-PR1 #LI-REMOTE #Associate #Contract

","ClinChoice, a global full-service CRO, is seeking an experienced Senior Regulatory Affairs Specialist Consultant (OTC products) for a 12-month contract in Denmark. The role involves working independently to provide regulatory input and technical guidance on local regulatory requirements, assessing the acceptability of quality documentation, preparing and submitting regulatory submissions, and maintaining compliance with local regulations. The ideal candidate has relevant experience in regulatory affairs, expertise across various regulatory classifications, and proficiency in Danish and English. ClinChoice offers a supportive culture, flexible remote work options, and competitive compensation.","Senior Regulatory Affairs Specialist Consultant (OTC products) for 12-month contract in Denmark",[],"https://boards.greenhouse.io/clinchoice/jobs/4535362101?utm_source=remoteliz.com","2025-02-14T11:57:33.669628-05:00",{"_855":2393,"_2041":2042,"_2043":2394,"_2045":89,"_2046":2395,"_2054":2396,"_13":2398,"_2062":2063,"_2064":2400,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2401,"_2086":2402,"_2088":2403,"_2090":2404,"_2092":2405,"_2098":2406,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2407,"_2105":2142},10402,"Senior PKPD Programmer Consultant (remote in US)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2397],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2399],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T11:54:33.464739-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Senior PKPD Programmer Consultant to join one of our clients and they focused on the development of novel cell-based cancer therapies.

RESPONSIBILITIES

Develop, validate and maintain SAS programs for data analysis in translational and early phase clinical trials
Responsible for providing QC oversight of CRO deliverables like ADaMs, and tables, listings and figures
Independently develop SAS or other programs and specifications for production of output to support study needs including publications, ad hoc analyses in a timely fashion
Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
Independently verify other programmers’ results
Adhere to company SOPs and department guidelines
Work concurrently on multiple projects
Troubleshoot technical and project issues
Help with infrastructure development of the department
Communicate effectively with internal cross-functional groups and external partners

QUALIFICATIONS

BS/BA degree in related discipline
At least 5 years of experience in statistical programming with clinical data and SAS
Experience in PK/PD area strongly preferred
Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
CDISC proficiency required
SAS/GRAPH experience desirable
Knowledge of appropriate regulations, industry standards and guidance documents
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways
Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-TT1 #LI-Remote #Senior #Contract

","ClinChoice is seeking a Senior PKPD Programmer Consultant to join one of their clients focused on developing novel cell-based cancer therapies. The ideal candidate will have 5+ years of experience in statistical programming with clinical data and SAS, as well as expertise in PK/PD area, CDISC, and regulations. As a client-facing role, the consultant will work independently while establishing high-trust relationships with clients. Responsibilities include developing, validating, and maintaining SAS programs for data analysis, providing QC oversight, and troubleshooting technical issues. ClinChoice offers a supportive culture, flexible remote work options, and opportunities for professional development. The company is an equal opportunity employer with a strong focus on diversity and inclusivity.","Senior PKPD Programmer Consultant job at ClinChoice: Develop SAS programs for clinical trials, provide QC oversight, and troubleshoot technical issues in a supportive culture.",[],"https://boards.greenhouse.io/clinchoice/jobs/4536138101?utm_source=remoteliz.com","2025-02-14T11:54:33.466781-05:00",{"_855":2409,"_2041":2042,"_2043":2362,"_2045":89,"_2046":2410,"_2054":2411,"_13":2413,"_2062":2063,"_2064":2415,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2416,"_2086":2417,"_2088":2418,"_2090":2419,"_2092":2420,"_2098":2421,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2422,"_2105":2142},10443,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2412],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2414],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T11:48:01.988837-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Main Job Tasks and Responsibilities:

Identify, assess, and pursue new business opportunities in the area of medical affairs, regulatory affairs and pharmacovigilance services.
Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.
Develop a deep appreciation for the client’s business challenges and organizational structure and use this insight to develop realistic and actionable account plans.
Contribute to the ongoing refinement of the company’s business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.
Work to exceed revenue targets that align with the company's growth objectives.

Education and Experience:

6+ years of sales and account management experience
Previous CRO experience is required.
Experience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory Affairs
Have a network of decision-makers in the life-sciences industry
Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders
Strong negotiation skills with a proven track record of closing complex business deals
Persuasive and compelling presentation and communication skills, both written and verbal
Ability to interpret business challenges and present quick and responsive high-level solutions
Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle
Positive employer and client references
BA, MBA, or equivalent experience

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-DNP

","ClinChoice is a global full-service CRO seeking a Director of Business Development to sell pharmacovigilance, medical affairs, and regulatory affairs services. The ideal candidate has 6+ years of sales and account management experience, previous CRO experience, and expertise in functional and consultancy sales with a focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory Affairs. They will build relationships with key decision-makers, develop account plans, and contribute to the company's business development approach. ClinChoice offers a supportive culture, flexible remote work options, and competitive compensation. The Director of Business Development will be responsible for identifying new business opportunities, lead generation, opportunity assessment, creating new accounts, and growing existing ones.","Director of Business Development at ClinChoice: Sell pharmacovigilance, medical affairs, and regulatory affairs services to clients in the life-sciences industry.",[],"https://boards.greenhouse.io/clinchoice/jobs/4527572101?utm_source=remoteliz.com","2025-02-14T11:48:01.991384-05:00",{"_855":2424,"_2041":2042,"_2043":2425,"_2045":89,"_2046":2426,"_2054":2427,"_13":2429,"_2062":2063,"_2064":2431,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2432,"_2086":2433,"_2088":2434,"_2090":2435,"_2092":2436,"_2098":2437,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2438,"_2105":2142},10384,"Project Director, Clinical Operations - Oncology",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2428],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2430],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T11:33:30.38984-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
Manage the projects at a global level and ensure consistent and continuous focus to Client’s specifications and satisfaction.
Meet and exceed the project’s deliverables: timelines, budget and quality.
Set project plans, monitor the adherence to the plans, proactively addresses with Project Leader/Project Director and his/her team any risk of variations.
Plan and manage the Project Boards for the assigned projects and agrees with the Global Head the project needs.
Responsible for the identification, resolution and escalation of any issues.
Achieve the Project KPIs, understand performance issues, share best practices and lessons learnt.
Define, plan and manage internal and external communications on the assigned projects planning and status.
Serve as a source of scientific and therapeutical expertise.
Give scientific and operational input to proposal development and contribute to the preparation of the strategic documents and bid defense meetings.
May act as Program Director for existing and potential new projects.
May participate in Monitor’s and Investigator’s Meeting.
Give input to the Clinical Research Operations Department Senior Director for periodic performance assessment on the basis of projects management experience.
Monitor and enforce compliance with ClinChoice systems, processes, policies and all applicable regulations.
Participate in review/design of processes and SOPs providing input based on projects management experience.
Maintain relationships with the Sponsors.

Education, Experience and Skills

University Degree in scientific and/or medical disciplines.
Eight years (at least) of Clinical Research experience in the CRO/Pharmaceutical industry and after gaining excellent knowledge in developing work organization models.
Strong knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Department Director, Clinical Research Director, Clinical Director, Oncology, Respiratory, Bid Defense, CRO, Contract Research Organisation

#LI-DNP

","ClinChoice is seeking a Project Director, Clinical Operations on a permanent basis. The ideal candidate will have 8+ years of experience in clinical research and strong knowledge of GCP-ICH guidelines. They will be responsible for managing projects at a global level, ensuring quality standards, timelines, and budget. The role involves developing strategies, setting project plans, monitoring progress, and identifying issues. ClinChoice offers a fulfilling career with opportunities to make a difference in people's lives. The company prioritizes diversity, inclusivity, and employee development. Flexible remote work options are available.","Clinical Research Director needed for global CRO, managing projects at a global level, ensuring quality standards, timelines, and budget.",[],"https://boards.greenhouse.io/clinchoice/jobs/4528192101?utm_source=remoteliz.com","2025-02-14T11:33:30.391794-05:00",{"_855":2440,"_2041":2042,"_2043":2441,"_2045":89,"_2046":2442,"_2054":2443,"_13":2445,"_2062":2063,"_2064":2447,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2448,"_2086":2449,"_2088":2450,"_2090":2451,"_2092":2452,"_2098":2453,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2454,"_2105":2142},10244,"Safety Medical Reviewer Consultant– Immunology",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2444],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2446],{"_16":1417,"_18":1418,"_20":1419,"_22":-5,"_23":1420,"_25":1421,"_27":1422,"_29":1423,"_31":-5},"2025-02-14T11:20:58.789645-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Job Description: Safety Medical Reviewer (Immunology)

Position Title: Safety Medical Reviewer – Immunology
Location: [Remote]
Employment Type: [Contract]

Job Summary:

We are seeking a highly skilled Safety Medical Reviewer with expertise in immunology to join our pharmacovigilance team. The incumbent will be responsible for medical review and assessment of safety data to ensure patient safety and regulatory compliance. The ideal candidate will have strong analytical skills, a deep understanding of immunological conditions, and experience in drug safety or pharmacovigilance.

Key Responsibilities:

Medical Review and Analysis:

Conduct detailed medical review of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements.
Assess adverse event reports related to immunology products and determine the causality and clinical significance.
Provide medical input for case narratives and data coding using MedDRA and WHO-DD.

Safety Signal Detection and Risk Assessment:

Contribute to safety signal detection activities and risk assessments specific to immunology therapeutic areas.
Collaborate with cross-functional teams to evaluate safety signals and support safety management strategies.

Regulatory Reporting and Compliance:

Ensure timely and accurate submission of safety reports to global health authorities.
Maintain compliance with regulatory guidelines, including FDA, EMA, and ICH regulations.

Collaboration and Communication:

Collaborate with clinical development, regulatory affairs, and other departments to provide medical expertise on safety issues.
Participate in safety review meetings and contribute to risk management plans.

Continuous Improvement and Training:

Contribute to the development of standard operating procedures (SOPs) and safety review processes.
Provide training and mentorship to junior safety reviewers and pharmacovigilance staff.

Qualifications and Experience:

Education:

Medical degree (MD or equivalent) with specialization in Immunology or related field preferred.
Advanced degree (e.g., PhD, PharmD) with significant immunology experience may be considered.

Experience:

Minimum [3] years of experience in pharmacovigilance, drug safety, or medical review, with a focus on immunology therapeutic areas.
Experience in clinical practice or clinical research in immunology is an advantage.

Skills and Competencies:

In-depth knowledge of immunological diseases and biologic therapies.
Strong analytical and clinical judgment skills.
Proficiency in safety databases (e.g., Argus, ArisG) and coding dictionaries (MedDRA, WHO-DD).
Excellent communication and presentation skills.
Detail-oriented with the ability to manage multiple tasks and prioritize effectively.

Preferred Qualifications:

Experience with safety signal detection and risk management in immunology.
Familiarity with global pharmacovigilance regulations (e.g., FDA, EMA, ICH).
Previous experience in a pharmaceutical or biotechnology company is a plus.

#LI-PB1

","We are seeking a highly skilled Safety Medical Reviewer with expertise in immunology to join our pharmacovigilance team. The incumbent will be responsible for medical review and assessment of safety data to ensure patient safety and regulatory compliance. With strong analytical skills, a deep understanding of immunological conditions, and experience in drug safety or pharmacovigilance, the ideal candidate will conduct detailed medical reviews, assess adverse event reports, and provide medical input for case narratives and data coding. The role also involves contributing to safety signal detection activities, collaborating with cross-functional teams, and maintaining compliance with regulatory guidelines. As a Safety Medical Reviewer, you will work closely with clinical development, regulatory affairs, and other departments to provide medical expertise on safety issues. With a minimum of 3 years of experience in pharmacovigilance, drug safety, or medical review, and a strong understanding of immunological diseases and biologic therapies, we invite you to apply for this exciting opportunity. Our team values detail-oriented individuals with excellent communication and presentation skills who can manage multiple tasks and prioritize effectively. With flexible remote work options and a competitive compensation package, ClinChoice offers a dynamic and supportive work environment that fosters growth and development. As part of our commitment to patient safety and regulatory compliance, we are seeking a highly skilled Safety Medical Reviewer to join our team and contribute to the development of standard operating procedures and safety review processes.","Safety Medical Reviewer Consultant– Immunology at ClinChoice: Conduct medical reviews, assess adverse event reports, and provide medical input for case narratives. Collaborate with cross-functional teams and maintain regulatory compliance.",[],"https://boards.greenhouse.io/clinchoice/jobs/4535276101?utm_source=remoteliz.com","2025-02-14T11:20:58.791673-05:00",{"_855":2456,"_2041":2042,"_2043":2457,"_2045":89,"_2046":2458,"_2054":2459,"_13":2461,"_2062":2063,"_2064":2463,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2464,"_2086":2465,"_2088":2466,"_2090":2467,"_2092":2468,"_2098":2469,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2470,"_2105":2142},10274,"Senior Clinical Project Manager",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2460],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2462],{"_16":897,"_18":898,"_20":899,"_22":-5,"_23":900,"_25":901,"_27":902,"_29":903,"_31":-5},"2025-02-14T11:19:28.3192-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice, is searching for an experienced Senior Project Manager to work with one of our pharmaceutical partners. This can be a home-based position, with occasional visits to the office. It will initially be a Fixed Term Contract until the end of December 2025.

Main Job Tasks and Responsibilities:

Supervising the assigned clinical research projects.
Coordinating and maintaining the planning of the activities for the assigned projects.
Management of the CRO by acting as primary contact, managing day-to-day relationships, raising issues as soon as they are identified.
Management of study budget, scope changes and financial reconciliation.
Preparation and coordination of scientific meetings incl. KOLs meeting, Investigators’ meeting, blinded review meeting.
Preparation, review and approval of Clinical Study Report (CSR) in cooperation with the Medical Writer and other required key team stakeholders.
Reporting to Company's senior management.
Operational management coordination of assigned projects.
Clinical Development Plan (CDP) definition in relation to studies’ operational aspects.
Interactions with all functions supporting the Clinical Development Plan.
Line Management of Clinical Project Managers (CPMs).
Supervises Clinical Research Associates (CRAs) activities, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.
Supervises the CTAs in archiving activities.
Collaborates in complying and enforcing Company procedures.

Education, Experience and Skills:

University Degree in scientific, pharmacy or other health related discipline, or equivalent.
Proven experience as Clinical Project Manager.
Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Knowledge of planning tools and planning principles.
Knowledge of clinical research process from Phase I/II through final regulatory submission.
Prior experience in electronic data capture preferred.
Fluent in English and Italian.
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Senior Clinical Project Manager, CPM, Project Management, Clinical Trials, EDC, TMF, ICH-GCP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

#LI-CM1 #LI-FULLTIME #TEMPORARY

","ClinChoice is seeking a Senior Clinical Project Manager to work with one of their pharmaceutical partners. The ideal candidate will have experience in clinical study design, trial operations, and regulatory requirements. They will be responsible for supervising projects, managing budgets, and coordinating scientific meetings. ClinChoice offers a supportive culture, flexible remote work options, and opportunities for professional development. As a Senior Clinical Project Manager, you will play a key role in accelerating the development and commercialization of innovative drugs and devices. With over 28 years of proven high-quality delivery, ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and employee well-being.","Senior Clinical Project Manager at ClinChoice: Manage clinical trials, coordinate scientific meetings, and supervise projects in a supportive culture.",[],"https://boards.greenhouse.io/clinchoice/jobs/4488245101?utm_source=remoteliz.com","2025-02-14T11:19:28.321425-05:00",{"_855":2472,"_2041":2042,"_2043":2473,"_2045":89,"_2046":2474,"_2054":2475,"_13":2477,"_2062":2063,"_2064":2595,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2596,"_2086":2597,"_2088":2598,"_2090":2599,"_2092":2600,"_2098":2601,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2602,"_2105":2142},10327,"Senior STDM Statistical Programmer Consultant 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ClinChoice is searching for a Senior/Principal Statistical Programmer Consultant to join one of our clients.

Main Job Tasks and Responsibilities:

The Senior/Principal Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks

Key Responsibilities:

Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Education and Experience:

Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Need to have Oncology TA experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role
Ability to proactively manage concurrent activities within a project
Proficient ability to influence relevant stakeholders on programming-related items

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-TT1 #LI-Remote #Senior #Contract

","ClinChoice is seeking a Senior/Principal Statistical Programmer Consultant to join one of their clients as a client-facing role. The position requires high technical skills, industry knowledge, and the ability to work independently while establishing trust with client counterparts. As a delivery-focused role, the consultant will lead and/or support aspects of programming efforts for clinical studies or projects. Key responsibilities include implementing statistical programming, ensuring quality, and contributing to best practices. The ideal candidate has 5-6 years of clinical programming experience, including Oncology TA experience, and strong communication skills. ClinChoice offers a supportive culture, flexible remote work options, and opportunities for professional development.","Senior Statistical Programmer Consultant needed for client-facing role with high technical skills and industry knowledge",[],"https://boards.greenhouse.io/clinchoice/jobs/4535935101?utm_source=remoteliz.com","2025-02-14T11:12:27.255726-05:00",{"_855":2604,"_2041":2042,"_2043":2441,"_2045":89,"_2046":2605,"_2054":2606,"_13":2608,"_2062":2063,"_2064":2610,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2611,"_2086":2612,"_2088":2613,"_2090":2614,"_2092":2615,"_2098":2616,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2617,"_2105":2142},10342,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2607],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2609],{"_16":345,"_18":346,"_20":347,"_22":-5,"_23":348,"_25":349,"_27":350,"_29":351,"_31":-5},"2025-02-14T10:03:44.658008-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Job Description: Safety Medical Reviewer (Immunology)

Position Title: Safety Medical Reviewer – Immunology
Location: [Remote]
Employment Type: [Contract]

Job Summary:

Key Responsibilities:

Medical Review and Analysis:

Conduct detailed medical review of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements.
Assess adverse event reports related to immunology products and determine the causality and clinical significance.
Provide medical input for case narratives and data coding using MedDRA and WHO-DD.

Safety Signal Detection and Risk Assessment:

Contribute to safety signal detection activities and risk assessments specific to immunology therapeutic areas.
Collaborate with cross-functional teams to evaluate safety signals and support safety management strategies.

Regulatory Reporting and Compliance:

Ensure timely and accurate submission of safety reports to global health authorities.
Maintain compliance with regulatory guidelines, including FDA, EMA, and ICH regulations.

Collaboration and Communication:

Collaborate with clinical development, regulatory affairs, and other departments to provide medical expertise on safety issues.
Participate in safety review meetings and contribute to risk management plans.

Continuous Improvement and Training:

Contribute to the development of standard operating procedures (SOPs) and safety review processes.
Provide training and mentorship to junior safety reviewers and pharmacovigilance staff.

Qualifications and Experience:

Education:

Medical degree (MD or equivalent) with specialization in Immunology or related field preferred.
Advanced degree (e.g., PhD, PharmD) with significant immunology experience may be considered.

Experience:

Minimum [3] years of experience in pharmacovigilance, drug safety, or medical review, with a focus on immunology therapeutic areas.
Experience in clinical practice or clinical research in immunology is an advantage.

Skills and Competencies:

In-depth knowledge of immunological diseases and biologic therapies.
Strong analytical and clinical judgment skills.
Proficiency in safety databases (e.g., Argus, ArisG) and coding dictionaries (MedDRA, WHO-DD).
Excellent communication and presentation skills.
Detail-oriented with the ability to manage multiple tasks and prioritize effectively.

Preferred Qualifications:

Experience with safety signal detection and risk management in immunology.
Familiarity with global pharmacovigilance regulations (e.g., FDA, EMA, ICH).
Previous experience in a pharmaceutical or biotechnology company is a plus.

#LI-PB1

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

","ClinChoice Canada Inc. is seeking a highly skilled Safety Medical Reviewer with expertise in immunology to join their pharmacovigilance team. The ideal candidate will have strong analytical skills, a deep understanding of immunological conditions, and experience in drug safety or pharmacovigilance. As a Safety Medical Reviewer, you will be responsible for medical review and assessment of safety data to ensure patient safety and regulatory compliance. You will conduct detailed medical reviews of Individual Case Safety Reports (ICSRs), assess adverse event reports related to immunology products, and provide medical input for case narratives and data coding. The role requires collaboration with cross-functional teams, participation in safety review meetings, and contribution to risk management plans. ClinChoice Canada Inc. is committed to inclusive, barrier-free recruitment and selection processes and values diversity. We are proud to be an equal opportunity employer. If you have a medical degree with specialization in Immunology or related field and at least 3 years of experience in pharmacovigilance, drug safety, or medical review, we encourage you to apply for this exciting opportunity.","Safety Medical Reviewer – Immunology job at ClinChoice Canada Inc., requiring strong analytical skills, immunological knowledge, and experience in pharmacovigilance.",[],"https://boards.greenhouse.io/clinchoice/jobs/4535283101?utm_source=remoteliz.com","2025-02-14T10:03:44.660274-05:00",{"_855":2619,"_2041":2042,"_2043":2620,"_2045":89,"_2046":2621,"_2054":2622,"_13":2624,"_2062":2063,"_2064":2626,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2627,"_2086":2628,"_2088":2629,"_2090":2630,"_2092":2631,"_2098":2632,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2633,"_2105":2142},10347,"Project Manager I or II",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2623],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2625],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T09:54:41.416817-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Clinical Project Manager I or II to join our in-house team. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As a Clinical Project Manager I or II you will be responsible for study execution, tracking and management of study delivery including oversight of vendor and CRO activity. Previous experience working with a CRO and managing complex clinical trials required. This role is a full-time, hybrid opportunity at our office in Horsham, PA.

Join our global team and help create a healthier world!

Main Job Tasks and Responsibilities:

Organizes and participates in Monitor’s and Investigator’s Meetings.
Performs, if necessary, co-monitoring visits for the assigned clinical projects.
Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
May act as Feasibility Associate (FEA) after appropriate and documented training.
Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
Regularly track all expenditure and review for consistency with trial budgets.
Organize quality check of filing of key study documentation.
Ensure all administrative close-out procedures are completed.
Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
PM I-Up to three (3) years of project management experience in the CRO/Pharmaceutical industry;
PM II-Three (3) years (at least) of Project Management experience in the CRO/Pharmaceutical industry or six (6) years (at least) of experience as CM/CRA in a CRO/Pharmaceutical industry.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Experience managing oncology and/or respiratory required.
Excellent English communication skills: written and verbal.
Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
Ability to travel as required.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

#LI-DNP

","ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance. They are recruiting for a Clinical Project Manager I or II to join their in-house team. The role involves study execution, tracking, and management of study delivery, including oversight of vendor and CRO activity. Previous experience working with a CRO and managing complex clinical trials is required. This full-time, hybrid opportunity offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company. ClinChoice values curiosity, ownership, and a drive to improve, and aims to contribute to a healthier world by accelerating the development and commercialization of innovative drugs and devices. The ideal candidate will have excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements, as well as experience managing oncology and/or respiratory trials. Excellent English communication skills are also required.","Join ClinChoice as a Clinical Project Manager I or II and contribute to the development and commercialization of innovative drugs and devices. Flexible remote work options and $4,000/year travel stipends available.",[],"https://boards.greenhouse.io/clinchoice/jobs/4527458101?utm_source=remoteliz.com","2025-02-14T09:54:41.420806-05:00",{"_855":2635,"_2041":2042,"_2043":2636,"_2045":89,"_2046":2637,"_2054":2638,"_13":2640,"_2062":2063,"_2064":2642,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2643,"_2086":2644,"_2088":2645,"_2090":2646,"_2092":2647,"_2098":2648,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2649,"_2105":2142},10224,"Freelance Clinical Research Associate (CRA) - Medical Device",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2639],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2641],{"_16":201,"_18":202,"_20":203,"_22":-5,"_23":204,"_25":205,"_27":206,"_29":207,"_31":-5},"2025-02-14T09:36:38.073154-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Freelance Clinical Research Associate (CRA) to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. In this role you will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Main Job Tasks and Responsibilities:

Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones;
Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures; 
May serve as the primary contact for clinical trial sites (e.g. site management);
Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….);
Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials;
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
Oversees and supports the development and execution of Investigator agreements and trial payments;
Responsible for clinical data review to prepare data for statistical analyses and publications;
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals;
May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant;
Supports project/study budget activities;
May act as Clinical Safety Coordinator;
Mentors team members;
May perform other duties assigned as needed;
Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
Should develop a strong understanding of the pipeline, product portfolio and business needs;
Generally, manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations.

Education and Experience:

Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required;
BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred;
Previous experience in clinical research or equivalent is required;
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…);
Clinical/medical background is a plus;
Medical device experience is highly preferred;
Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Good presentation and technical writing skills;
Good written and oral English communication skills;
Ability to lead small study teams to deliver critical milestones, as may be assigned;
Leadership required in alignment with Company Leadership Imperatives;
Connect - Develop collaborative relationships with key internal and external stakeholders;
Shape - Make recommendations for and actively participate in departmental process improvement activities;
Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations;
Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations;
Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated;
May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Keywords: Freelance Clinical Research Specialist, Clinical Trial, ICH-GCP, Regulatory, Medical Devices, Contract Research Organisation, CRO.

#LI-CM1 #LI-CONTRACT

","ClinChoice is seeking a Freelance Clinical Research Associate (CRA) to support clinical trials for a pharmaceutical company. The ideal candidate will have a minimum of a Bachelor's Degree in Life Science or related field, 4+ years of experience in clinical research, and relevant industry certifications. As a CRA, you will be responsible for executing clinical trials, managing study milestones, and collaborating with site personnel, IRBs/ECs, and company personnel. You will also contribute to the development of clinical trial documents, manage investigational devices, and perform data review. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. The company offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company.","Freelance Clinical Research Associate (CRA) position at ClinChoice, supporting clinical trials for pharmaceutical companies, with opportunities for growth and development.",[],"https://boards.greenhouse.io/clinchoice/jobs/4531797101?utm_source=remoteliz.com","2025-02-14T09:36:38.074757-05:00",{"_855":2651,"_2041":2042,"_2043":2652,"_2045":89,"_2046":2653,"_2054":2654,"_13":2656,"_2062":2063,"_2064":2658,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2659,"_2086":2660,"_2088":2661,"_2090":2662,"_2092":2663,"_2098":2664,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2665,"_2105":2142},10228,"Client Success Manager",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2655],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2657],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T09:20:05.707354-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Client Success Manager on a permanent basis. This is a remote position, preferably in the Maryland / Delaware / Washington DC area.

The Client Success Manager is an integral, hands-on leader for a group of our clients, providing vision, strategic counsel, agency expertise, accountability, and growth across our partnerships.

The position requires proven success in delivering on organic growth, client relationship development and strategic insight for supporting the diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer). This means elevating transactional client engagements to consultative, value-driven ones; generating, qualifying, and defining new opportunities across teams within client organizations; earning the respect and sought-after counsel of senior client stakeholders; and pushing the work to drive impactful results. Previous experience working with a CRO and managing pharmaceutical and biotechnology accounts required.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Cultivate and lead the relationship with existing client base within the Life Sciences, Pharmaceutical, Medical Devices, and Biotech industry sectors for pharmacovigilance, regulatory, clinical and technology services.
Previous experience working with a CRO and managing the services provided to pharmaceutical and biotechnology companies required.
Work with the existing clients and advise them on strategic issues to advance long-term partnership with them.
Support sales activity, utilizing expertise and other resources, such as domain experts and client relations team.
Support new business as part of expanding ClinChoice's footprint within the market; typically serving as primary point to engage with clients.
Advise on any new technology development and collaborate with internal team/external consultants to support design and implementation of new technology.
Lead and coordinate RFP responses, client presentations and any activities to facilitate the business expansion with existing clients.
Establish good working knowledge of services offerings.

Education, Experience and Skills

Bachelor’s degree in a technical or business field and advanced university degree preferred (e.g., MBA, MS, PhD).
Require 5+ years of applicable business, sales, consulting experience or combined industry experience.
Experience selling CRO services is mandatory.
Minimum of 2-3 years leading major programs and projects for Global 1000 companies; experience at a top consulting firm a strong plus.
Possess clinical, safety or regulatory domain knowledge so as to understand client’s marketplace, competitive landscape and business drivers, and be able to speak intelligently in these terms.
Collaborative player that can effectively influence others at all levels.
Experience leading/facilitating complex workshops with tangible results.
Strong executive level presentation and communication skills.
Ability to work independently, manage time and create plans to achieve personal goals, while focusing on the success of the team is critical.
Ability to think strategically and act tactically in a dynamic environment is essential.
Customer Relationship Management skills.
Requires excellent interpersonal, written and oral communication and presentation skills.
Ability to communicate complex technical analysis to technical and non-technical audiences.
Ability to create an environment conducive to contribution, growth, and achievement with an emphasis on customer-focused behavior.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Client Success Manager, Customer Success Manager, CRO, Contract Research Organisation

#LI-VH #LI-Remote #LI-Intermediate #LI-FULLTIME

","ClinChoice is seeking a Client Success Manager to lead the relationship with existing client base within the Life Sciences, Pharmaceutical, Medical Devices, and Biotech industry sectors. The ideal candidate will have 5+ years of applicable business, sales, consulting experience or combined industry experience, selling CRO services, and leading major programs and projects for Global 1000 companies. They should possess clinical, safety, or regulatory domain knowledge, strong executive level presentation and communication skills, and ability to work independently and manage time effectively. The position is remote, with flexible options in the Maryland / Delaware / Washington DC area.","Client Success Manager at ClinChoice: lead client relationships, drive growth, and deliver strategic counsel for pharmaceutical, biotechnology, and medical device companies.",[],"https://boards.greenhouse.io/clinchoice/jobs/4517804101?utm_source=remoteliz.com","2025-02-14T09:20:05.709439-05:00",{"_855":2667,"_2041":2042,"_2043":2668,"_2045":89,"_2046":2669,"_2054":2670,"_13":2672,"_2062":2063,"_2064":2674,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2675,"_2086":2676,"_2088":2677,"_2090":2678,"_2092":2679,"_2098":2680,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2681,"_2105":2142},10172,"Statistical Programmer/Analyst III- Permanent Role",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2671],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2673],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-14T09:19:35.336764-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

This is an advanced-level Statistical Programmer/Analyst III position. Key responsibilities and skills may include, but are not limited to:
• Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
• Develop SDTM specifications and generate SDTM datasets using SAS.
• Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
• Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
• Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
• Analyze information and develop innovative solutions to programming and data analysis challenges.
• Actively communicate with statisticians for statistical input and analysis interpretation.
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team lead and contribute to department initiative.
• Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.

Qualifications

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 years of clinical programming experience.
• Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
• Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
• Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Detail-oriented and ability to learn and adapt to changes.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-DNP

","ClinChoice is seeking a Statistical Programmer/Analyst III for a permanent role in Ontario, Canada. The ideal candidate will have 3+ years of clinical programming experience, proficiency in high-level computing languages such as SAS and Python, and strong communication skills. This hybrid role involves annotating Case Report Forms, developing SDTM specifications, and analyzing data to support clinical studies. ClinChoice offers a quality-focused culture, flexible remote work options, and opportunities for professional development and growth. The company is committed to diversity and inclusivity, with a strong focus on employee training and retention.","Statistical Programmer/Analyst III role at ClinChoice in Ontario, Canada, requiring clinical programming experience and proficiency in SAS and Python.",[],"https://boards.greenhouse.io/clinchoice/jobs/4517893101?utm_source=remoteliz.com","2025-02-14T09:19:35.338764-05:00",{"_855":2683,"_2041":2042,"_2043":2145,"_2045":89,"_2046":2684,"_2054":2685,"_13":2687,"_2062":2063,"_2064":2689,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2690,"_2086":2691,"_2088":2692,"_2090":2693,"_2092":2694,"_2098":2695,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2696,"_2105":2142},10162,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2686],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2688],{"_16":201,"_18":202,"_20":203,"_22":-5,"_23":204,"_25":205,"_27":206,"_29":207,"_31":-5},"2025-02-14T09:04:09.638614-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Clinical Project Manager II to join our in-house team in Belgium. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Join our global team and help create a healthier world!

Main Job Tasks and Responsibilities:

Organizes and participates in Monitor’s and Investigator’s Meetings.
Performs, if necessary, co-monitoring visits for the assigned clinical projects.
Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
May act as Feasibility Associate (FEA) after appropriate and documented training.
Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
Regularly track all expenditure and review for consistency with trial budgets.
Organize quality check of filing of key study documentation.
Ensure all administrative close-out procedures are completed.
Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
Proven Project Management experience in the CRO/Pharmaceutical industry, in addition previous experience as CM/CRA in a CRO/Pharmaceutical industry.
Experience working on Oncology or Respiratory studies.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Experience managing oncology and/or respiratory required.
Excellent English communication skills: written and verbal.
Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
Ability to travel as required.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

#LI-CM1 #LI-Hybrid #LI-Intermediate #LI-FULLTIME

","ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance. They are recruiting for a Clinical Project Manager II to join their in-house team in Belgium. The ideal candidate will have proven experience working on Oncology or Respiratory studies, managing complex clinical trials, and collaborating with a talented team. As a Clinical Project Manager II, you will be responsible for study execution, tracking, and management of study delivery, including oversight of vendor and CRO activity. ClinChoice offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company. Join their global team and help create a healthier world! With over 28 years of proven high-quality delivery and results across all services, ClinChoice is on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.","Join ClinChoice as Clinical Project Manager II in Belgium. Manage complex clinical trials, collaborate with a talented team, and contribute to a healthier world. Flexible remote work options and $4,000/year travel stipends available.",[],"https://boards.greenhouse.io/clinchoice/jobs/4528217101?utm_source=remoteliz.com","2025-02-14T09:04:09.64097-05:00",{"_855":2698,"_2041":2042,"_2043":2699,"_2045":89,"_2046":2700,"_2054":2701,"_13":2703,"_2062":2063,"_2064":2705,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2706,"_2086":2707,"_2088":2708,"_2090":2709,"_2092":-5,"_2098":2710,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2711,"_2105":2042},5329,"Senior Clinical Project Manager - Oncology/Respiratory",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2702],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2704],{"_16":681,"_18":682,"_20":683,"_22":-5,"_23":684,"_25":685,"_27":686,"_29":687,"_31":-5},"2025-02-06T06:20:59.084404-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house German team as a Senior Clinical Project Manager. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As Senior Clinical Project Manager you will be responsible for leading cross-functional teams and managing complex projects. You will also ensure quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations. Previous experience working with a CRO, managing oncology and/or respiratory trials is required. This role is a full-time, remote opportunity.

Join our global team and help improve peoples' lives!

Main Job Tasks and Responsibilities:

Manage and coordinate the assigned clinical projects.
Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.
Assure the proper timelines of the assigned projects.
Manage the budget for the project.
Monitor the workload and the performance of the project team.
Plan and monitor the tasks of the team in the specific areas.
Coordinate the Clinical Research Associates and Clinical Monitors activity.
Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
Collaborate with the CTAs in archiving activities.
Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
Deliver project specific trainings.
Organize and participate in Monitor and Investigator Meetings.
Organize or take part in the periodic project update meetings.
Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
Inform the Project Director/Leader about any issues.
Perform co-monitoring visits for the assigned clinical projects as necessary.
Act as a tutor for Project Coordinators and Project Manager I.
Maintain relationships with the Sponsor, including providing project updates.
Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.
Collaborate in complying and enforcing Company procedures.

Education, Experience and Skills:

Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Eight (8) years (at least) of clinical research experience in Project Management.
Previous experience managing oncology and/or respiratory studies is required.
Previous CRA experience is highly desirable.
Previous CRO experience is required.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
Prior experience in electronic data capture preferred.
Fluent in English.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

Key words: Senior Project Manager, Senior Clinical Project Manager, Senior Study Manager, Senior Clinical Trial Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, respiratory, CRO, Contract Research Organization

#LI-CM1 #LI-Senior #LI-FULLTIME

","ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance. They are looking for a dynamic person to join their in-house German team as a Senior Clinical Project Manager. The role involves leading cross-functional teams, managing complex projects, ensuring quality of services, and collaborating with clients and investigators. Previous experience working with a CRO, managing oncology and/or respiratory trials is required. This is a full-time, remote opportunity that offers flexible work options, travel stipends, and equity in a fast-growing company. The ideal candidate will have at least 8 years of clinical research experience, knowledge of GCP/ICH Guidelines, and proficiency in Microsoft Office.","Join ClinChoice as a Senior Clinical Project Manager and lead cross-functional teams on complex projects, ensuring quality services and collaborating with clients and investigators.","https://boards.greenhouse.io/clinchoice/jobs/4528209101?utm_source=remoteliz.com","2025-02-06T07:20:23.903006-05:00",{"_855":2713,"_2041":2042,"_2043":2699,"_2045":89,"_2046":2714,"_2054":2715,"_13":2717,"_2062":2063,"_2064":2719,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2720,"_2086":2721,"_2088":2722,"_2090":2723,"_2092":-5,"_2098":2724,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2725,"_2105":2042},5324,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2716],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2718],{"_16":1897,"_18":1898,"_20":1899,"_22":-5,"_23":1900,"_25":1901,"_27":1902,"_29":1903,"_31":-5},"2025-02-06T06:20:43.715602-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house UK team as a Senior Clinical Project Manager. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As Senior Clinical Project Manager you will be responsible for leading cross-functional teams and managing complex projects. You will also ensure quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations. Previous experience working with a CRO, managing oncology and respiratory trials is required. This role is a full-time, remote opportunity.

Join our global team and help improve peoples' lives!

Main Job Tasks and Responsibilities:

Manage and coordinate the assigned clinical projects.
Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.
Assure the proper timelines of the assigned projects.
Manage the budget for the project.
Monitor the workload and the performance of the project team.
Plan and monitor the tasks of the team in the specific areas.
Coordinate the Clinical Research Associates and Clinical Monitors activity.
Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
Collaborate with the CTAs in archiving activities.
Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
Deliver project specific trainings.
Organize and participate in Monitor and Investigator Meetings.
Organize or take part in the periodic project update meetings.
Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
Inform the Project Director/Leader about any issues.
Perform co-monitoring visits for the assigned clinical projects as necessary.
Act as a tutor for Project Coordinators and Project Manager I.
Maintain relationships with the Sponsor, including providing project updates.
Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.
Collaborate in complying and enforcing Company procedures.

Education, Experience and Skills:

Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Eight (8) years (at least) of clinical research experience in Project Management.
Previous experience managing oncology and/or respiratory studies is required.
Previous CRA experience is highly desirable.
Previous CRO experience is required.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
Prior experience in electronic data capture preferred.
Fluent in English.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

#LI-LG1 #LI-Senior #LI-FULLTIME

","ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance. They are looking for a dynamic Senior Clinical Project Manager to join their in-house UK team. The role involves leading cross-functional teams, managing complex projects, ensuring quality of services, and collaborating with clients. Previous experience working with a CRO, managing oncology and respiratory trials is required. This is a full-time, remote opportunity that offers flexible work options, $4,000/year travel stipends, and equity in a fast-growing company. The ideal candidate will have 8+ years of clinical research experience, knowledge of GCP/ICH Guidelines, and proficiency in Microsoft Office.","Join ClinChoice as a Senior Clinical Project Manager and lead cross-functional teams on complex projects, ensuring quality services and collaborating with clients.","https://boards.greenhouse.io/clinchoice/jobs/4528206101?utm_source=remoteliz.com","2025-02-06T07:25:46.265263-05:00",{"_855":2727,"_2041":2042,"_2043":2728,"_2045":89,"_2046":2729,"_2054":2730,"_13":2732,"_2062":2063,"_2064":2734,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2735,"_2086":2736,"_2088":2737,"_2090":2738,"_2092":-5,"_2098":2739,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2740,"_2105":2042},5323,"Clinical Research Department Director",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2731],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2733],{"_16":897,"_18":898,"_20":899,"_22":-5,"_23":900,"_25":901,"_27":902,"_29":903,"_31":-5},"2025-02-06T06:20:42.196677-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

The Clinical Research Department Director is responsible for the accountability for the accountability of the assigned clinical projects in order to ensure that clinical projects are delivered on time, within budget and with the required quality standards. Applicants must have a strong background with Oncology and/or Respiratory trials.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
Manage the projects at a global level and ensure consistent and continuous focus to Client’s specifications and satisfaction.
Meet and exceed the project’s deliverables: timelines, budget and quality.
Set project plans, monitor the adherence to the plans, proactively addresses with Project Leader/Project Director and his/her team any risk of variations.
Plan and manage the Project Boards for the assigned projects and agrees with the Global Head the project needs.
Responsible for the identification, resolution and escalation of any issues.
Achieve the Project KPIs, understand performance issues, share best practices and lessons learnt.
Define, plan and manage internal and external communications on the assigned projects planning and status.
Serve as a source of scientific and therapeutical expertise.
Give scientific and operational input to proposal development and contribute to the preparation of the strategic documents and bid defense meetings.
May act as Program Director for existing and potential new projects.
May participate in Monitor’s and Investigator’s Meeting.
Give input to the Clinical Research Operations Department Senior Director for periodic performance assessment on the basis of projects management experience.
Monitor and enforce compliance with ClinChoice systems, processes, policies and all applicable regulations.
Participate in review/design of processes and SOPs providing input based on projects management experience.
Maintain relationships with the Sponsors.

Education, Experience and Skills

University Degree in scientific and/or medical disciplines.
Eight years (at least) of Clinical Research experience in the CRO/Pharmaceutical industry and after gaining excellent knowledge in developing work organization models.
Strong knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Department Director, Clinical Research Director, Clinical Director, Oncology, Respiratory, Bid Defense, CRO, Contract Research Organisation

#LI-LG1 #LI-Senior #LI-FULLTIME

","ClinChoice is seeking a Clinical Research Department Director to join their in-house team as a permanent remote position. The ideal candidate will have strong background in Oncology and/or Respiratory trials, with 8+ years of experience in clinical research operations, GCP-ICH guidelines, and regulatory requirements. As a director, you will be responsible for managing projects at a global level, ensuring quality standards, timelines, and budgets are met. You will also develop strategies, manage internal and external communications, and provide scientific expertise. ClinChoice offers a fulfilling career with opportunities to make a difference in people's lives, flexible remote work options, and a competitive salary.","Clinical Research Department Director at ClinChoice: Manage global clinical projects, ensure quality standards, and develop strategic plans.","https://boards.greenhouse.io/clinchoice/jobs/4529350101?utm_source=remoteliz.com","2025-02-06T07:26:35.797359-05:00",{"_855":2742,"_2041":2042,"_2043":2728,"_2045":89,"_2046":2743,"_2054":2744,"_13":2746,"_2062":2063,"_2064":2748,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2749,"_2086":2750,"_2088":2751,"_2090":2752,"_2092":-5,"_2098":2753,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2754,"_2105":2042},5322,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2745],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2747],{"_16":1897,"_18":1898,"_20":1899,"_22":-5,"_23":1900,"_25":1901,"_27":1902,"_29":1903,"_31":-5},"2025-02-06T06:20:40.919067-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
Manage the projects at a global level and ensure consistent and continuous focus to Client’s specifications and satisfaction.
Meet and exceed the project’s deliverables: timelines, budget and quality.
Set project plans, monitor the adherence to the plans, proactively addresses with Project Leader/Project Director and his/her team any risk of variations.
Plan and manage the Project Boards for the assigned projects and agrees with the Global Head the project needs.
Responsible for the identification, resolution and escalation of any issues.
Achieve the Project KPIs, understand performance issues, share best practices and lessons learnt.
Define, plan and manage internal and external communications on the assigned projects planning and status.
Serve as a source of scientific and therapeutical expertise.
Give scientific and operational input to proposal development and contribute to the preparation of the strategic documents and bid defense meetings.
May act as Program Director for existing and potential new projects.
May participate in Monitor’s and Investigator’s Meeting.
Give input to the Clinical Research Operations Department Senior Director for periodic performance assessment on the basis of projects management experience.
Monitor and enforce compliance with ClinChoice systems, processes, policies and all applicable regulations.
Participate in review/design of processes and SOPs providing input based on projects management experience.
Maintain relationships with the Sponsors.

Education, Experience and Skills

University Degree in scientific and/or medical disciplines.
Eight years (at least) of Clinical Research experience in the CRO/Pharmaceutical industry and after gaining excellent knowledge in developing work organization models.
Strong knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Department Director, Clinical Research Director, Clinical Director, Oncology, Respiratory, Bid Defense, CRO, Contract Research Organisation

#LI-LG1 #LI-Senior #LI-FULLTIME

","ClinChoice is seeking a Clinical Research Department Director to join their in-house team as a permanent remote position. The ideal candidate will have a strong background in Oncology and/or Respiratory trials, with at least 8 years of experience in clinical research operations. Responsibilities include developing project strategies, managing projects globally, ensuring quality standards, and providing scientific expertise. ClinChoice offers a fulfilling career, flexible remote work options, and a commitment to diversity and inclusivity. As part of the team, you will contribute to making a difference in people's lives and experience a rewarding career. With over 28 years of proven high-quality delivery, ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical companies.","Clinical Research Department Director at ClinChoice: Develop project strategies, manage projects globally, ensure quality standards, and provide scientific expertise in Oncology and/or Respiratory trials. Flexible remote work options available.","https://boards.greenhouse.io/clinchoice/jobs/4528196101?utm_source=remoteliz.com","2025-02-06T07:27:39.329846-05:00",{"_855":2756,"_2041":2042,"_2043":2728,"_2045":89,"_2046":2757,"_2054":2758,"_13":2760,"_2062":2063,"_2064":2762,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2763,"_2086":2764,"_2088":2765,"_2090":2766,"_2092":-5,"_2098":2767,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2768,"_2105":2042},5320,{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2759],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2761],{"_16":681,"_18":682,"_20":683,"_22":-5,"_23":684,"_25":685,"_27":686,"_29":687,"_31":-5},"2025-02-06T06:20:38.057827-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
Manage the projects at a global level and ensure consistent and continuous focus to Client’s specifications and satisfaction.
Meet and exceed the project’s deliverables: timelines, budget and quality.
Set project plans, monitor the adherence to the plans, proactively addresses with Project Leader/Project Director and his/her team any risk of variations.
Plan and manage the Project Boards for the assigned projects and agrees with the Global Head the project needs.
Responsible for the identification, resolution and escalation of any issues.
Achieve the Project KPIs, understand performance issues, share best practices and lessons learnt.
Define, plan and manage internal and external communications on the assigned projects planning and status.
Serve as a source of scientific and therapeutical expertise.
Give scientific and operational input to proposal development and contribute to the preparation of the strategic documents and bid defense meetings.
May act as Program Director for existing and potential new projects.
May participate in Monitor’s and Investigator’s Meeting.
Give input to the Clinical Research Operations Department Senior Director for periodic performance assessment on the basis of projects management experience.
Monitor and enforce compliance with ClinChoice systems, processes, policies and all applicable regulations.
Participate in review/design of processes and SOPs providing input based on projects management experience.
Maintain relationships with the Sponsors.

Education, Experience and Skills

University Degree in scientific and/or medical disciplines.
Eight years (at least) of Clinical Research experience in the CRO/Pharmaceutical industry and after gaining excellent knowledge in developing work organization models.
Strong knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Department Director, Clinical Research Director, Clinical Director, Oncology, Respiratory, Bid Defense, CRO, Contract Research Organisation

#LI-LG1 #LI-Senior #LI-FULLTIME

","ClinChoice is seeking a Clinical Research Department Director to join their in-house team as a permanent remote position. The ideal candidate will have a strong background in Oncology and/or Respiratory trials, with at least 8 years of experience in clinical research operations. Responsibilities include developing project strategies, managing projects globally, ensuring quality standards, and providing scientific expertise. ClinChoice offers a fulfilling career, flexible remote work options, and a chance to contribute to global healthcare. The company values diversity and inclusivity, and has an equal opportunity policy.","Clinical Research Department Director at ClinChoice: Remote position with 8+ years of clinical research experience required.","https://boards.greenhouse.io/clinchoice/jobs/4528200101?utm_source=remoteliz.com","2025-02-06T07:29:30.463444-05:00",{"_855":2770,"_2041":2042,"_2043":2771,"_2045":89,"_2046":2772,"_2054":2773,"_13":2774,"_2062":2063,"_2064":2776,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2777,"_2086":2778,"_2088":2779,"_2090":2780,"_2092":-5,"_2098":2781,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2782,"_2105":2042},5243,"Associate Director/Director - Biostatistics consultant (Inflammatory and Immune diseases)",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[],[2775],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-06T06:15:26.061344-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Associate Director/Director, Biostatistics to join one of our clients.

SUMMARY

We are seeking an Associate Director/Director of Biostatistics. Reporting to the VP of Biometrics. In this position you will be acting as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistic input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity. Rich experience leading Integrated Summary of Safety, DSUR, IB would be preferred.

RESPONSIBILITIES

Key contributor on regulatory submissions and communication with global regulatory authorities
Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Client clinical studies
Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
Oversee and lead the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Client studies
Evaluate alternative or innovative approaches to statistical methods and study design
Build relationships with CROs and other external partners to achieve results for specific project needs
Ensure the delivery of high quality and timely reports to project teams and clinical trial team

QUALIFICATION

PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered
A minimum of 10 years’ experience in progressive and relevant clinical trial experience
Experience working in a matrix organization
Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
Experience managing CROs and other data vendors
Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
Ability to keep pace in a fast-moving organization and navigate ambiguity
Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment.
Knowledge and proficiency in SAS or R and other industry computational tools
Knowledge of CDISC standard including SDTM, ADaM
Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
Experience in planning, running and documenting simulations, including clinical trial simulations
Experience working with in a remote virtual environment

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-TT1 #LI-Remote #Senior #Contract

","ClinChoice is seeking an Associate Director/Director of Biostatistics to join one of their clients as a client-facing role. The successful candidate will provide technical leadership and statistical support on the design, conduct, and execution of clinical studies. They will partner closely with cross-functional teams and provide expert biostatistic input on development plans, regulatory interactions, and study design. The ideal candidate has a PhD in statistics or MS in statistics, biostatistics, or mathematics, with at least 10 years of experience in progressive and relevant clinical trial experience. They should have excellent communication skills, ability to work independently, and manage CROs and data vendors. ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.","Biostatistics Director role at ClinChoice, providing technical leadership on clinical studies design, conduct, and execution.","https://boards.greenhouse.io/clinchoice/jobs/4529981101?utm_source=remoteliz.com","2025-02-06T08:52:08.529072-05:00",{"_855":2784,"_2041":2042,"_2043":2785,"_2045":89,"_2046":2786,"_2054":2787,"_13":2788,"_2062":2063,"_2064":2790,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2791,"_2086":2792,"_2088":2793,"_2090":2794,"_2092":2795,"_2098":2798,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2799,"_2105":2042},5004,"Clinical Data Acquisition and Strategy Manager",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[],[2789],{"_16":345,"_18":346,"_20":347,"_22":-5,"_23":348,"_25":349,"_27":350,"_29":351,"_31":-5},"2025-02-03T03:08:27.538957-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Data Acquisition and Strategy Manager to join one of our clients.

SUMMARY

The role defines and facilitates the participant data journey, identifying participant data sources, transport methods, ingestion to client ecosystem and mitigating potential challenges to ensure understanding, consistency and integrity of the participant data. The role will collaborate with technical and clinical teams across Client to define participant data requirements and challenges to provide short- and long-term solutions and be a subject matter expert within data management and statistics to facilitate effective data use and risk mitigation.

RESPONSIBILITIES

A key part of the study team providing technical and procedural guidance on data ingestion and chain of clinical data custody; will be front facing with CRO’s, vendors and internal teams. Identify participant data sources and document; creation of study data flow maps to show the clinical data journey. Input to technical data specifications for data ingestion and use at Client. Primary point for nonstandard data ingestion and defining the data demand with enablement teams – internal and external facing Define and conduct data ingestion reconciliation against data transfer specifications Perform Risk Assessment for study-level participant data content and provide guidance on risk mitigation. Assess that the right data is being collected and educating the study teams Support digital health technologies and eSource data use providing set up and technical support to the wider teams and maintaining data integrity, input to long term solution planning. Assess and define new and existing strategic vendors to support data ingestion and data quality; be part of the assessment team to understand vendor capabilities and limitations. Work closely with data enablement teams on data ingestion, harmonization, transformation, validation, and automation for the Clinical Data platform Be a key contributor to internal business and process improvement by ensuring compliance to latest technology and regulatory guidance. Involvement in Client initiative implementation including digital protocol, automation, tokenization, data optimization, workflow definition. Ensure that the data governance framework is followed for participant data.

QUALIFICATION

Strong knowledge of modern data management platforms and technologies, including Big Data, Lakehouse, and modern data ingestion and integration. Must have experience with clinical data sets, EDC and non-crf data, and have strong analytical skills with the ability to work with a variety of large and complex datasets including (but not limited to) basic research datasets and clinical data.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ('PIPEDA') , personal information is collected under the authority of the Act and will only be used for candidate selection.

#LI-TT1 #LI-Remote #Senior #Contract

","ClinChoice is seeking a Clinical Data Acquisition and Strategy Manager to join their team. This role involves defining and facilitating the participant data journey, collaborating with technical and clinical teams to ensure data integrity and consistency. Key responsibilities include identifying data sources, creating data flow maps, providing technical guidance on data ingestion, conducting risk assessments, supporting digital health technologies, assessing vendors, and contributing to internal process improvements. The ideal candidate should have strong knowledge of modern data management platforms, experience with clinical datasets, EDC systems, and non-CRF data, along with analytical skills to handle large and complex datasets.","Define and manage participant data strategies, collaborate on technical solutions, ensure data integrity, assess risks, support digital health technologies, and contribute to process improvements at ClinChoice.",[2796,2797],"Equal opportunity employer","Supportive culture","https://boards.greenhouse.io/clinchoice/jobs/4529017101?utm_source=remoteliz.com","2025-02-03T03:26:54.097049-05:00",{"_855":2801,"_2041":2042,"_2043":2802,"_2045":89,"_2046":2803,"_2054":2804,"_13":2805,"_2062":2063,"_2064":2807,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2808,"_2086":2809,"_2088":2810,"_2090":2811,"_2092":2812,"_2098":2816,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2817,"_2105":2042},4576,"Clinical Research Associate",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[],[2806],{"_16":1897,"_18":1898,"_20":1899,"_22":-5,"_23":1900,"_25":1901,"_27":1902,"_29":1903,"_31":-5},"2025-01-31T04:36:50.937736-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice, is searching for a Freelance Clinical Research Associate to join one of our partner companies, a global health care company.

Main Job Tasks and Responsibilities:

On-site interim monitoring visits and study site closure visits according to the monitoring plan.
Collection of essential documents from the site(s).
Assure accurate, complete and current source documents are being maintained. Collect study specific data, as needed.
Ensure the study protocol is being followed and conducted in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and applicable regulatory guidance.
Meet with the investigator and study site personnel to discuss the study status and compliance issues (if applicable). Motivate/influence them to meet study timelines.
Ensure electronic Case Report Forms (eCRFs) are a complete and accurate representation of the source documents and assure timely submission of data, and query resolution including appropriate reporting and follow-up for all safety events by site personnel.
Ensure safety and protection of study subjects.
Train study site personnel on the protocol and applicable regulatory requirements with pertinent project team members. Retrain as necessary.
Appropriately elevate serious or outstanding issues to the Company.
Administration of clinical trial, checking and maintaining study files.
Assure study product supply, accountability, and storage procedures are acceptable.
Coordination of Clinical Study Supplies.
Queries resolution.

Education and Experience:

University Degree in scientific medical or paramedical disciplines.
Previous proven experience as a CRA, performing on-site monitoring activities.
Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirement.
Fluent in English
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
Willingness to travel

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Keywords: Freelance Clinical Research Associate, Freelance CRA, Site Management, Monitor, Monitoring, Training, Travel, Contract Research Organisation, CRO.

#LI-CM1 #LI-REMOTE

","ClinChoice is seeking a Freelance Clinical Research Associate to work with a global healthcare company. The role involves on-site monitoring, ensuring compliance with GCP/ICH guidelines, data collection, and training site personnel. This position offers the security of working for a global CRO with additional career opportunities.","Join ClinChoice as a Freelance CRA to perform clinical trial monitoring, ensure regulatory compliance, collect data, and support study sites while enjoying professional development and a supportive culture.",[2813,2814,2797,2815],"Global career opportunities","Professional development","Travel stipend","https://boards.greenhouse.io/clinchoice?utm_source=remoteliz.com","2025-01-31T05:37:42.084263-05:00",{"_855":2819,"_2041":2042,"_2043":2820,"_2045":89,"_2046":2821,"_2054":2822,"_13":2824,"_2062":2063,"_2064":2826,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2827,"_2086":2828,"_2088":2829,"_2090":2830,"_2092":2831,"_2098":2833,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2834,"_2105":2042},4571,"Senior Statistician",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[2823],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2825],{"_16":1897,"_18":1898,"_20":1899,"_22":-5,"_23":1900,"_25":1901,"_27":1902,"_29":1903,"_31":-5},"2025-01-31T04:36:37.770228-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Principal Statistician to join our biometrics team. This is a full-time permanent opportunity with REMOTE work arrangement at Stirling, UK office.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and a supportive culture. We are recruiting a principal statistician who will be responsible for protocol development and statistical analysis plans for assigned studies. Additional tasks include providing statistical oversight to studies and ensuring adequate quality and consistency with project requirements.

Job Responsibilities

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate, and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for the validity of the analysis and exploring alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensures project-wide consistency.
Effectively mentor peers with regard to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Requirements:

MS or PhD in Statistics, Biostatistics, or related field. PhD with 3-5 years of experience or MS with 7-8 years of experience.
Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA.

The Application Process

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

Our Company Ethos

ClinChoice is an equal-opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #FTE

","ClinChoice is seeking a Principal Statistician to join their biometrics team. The role involves protocol development, statistical analysis plans, and providing statistical oversight for studies. The position offers remote work opportunities with benefits including professional development and a supportive culture.","Join ClinChoice as a Principal Statistician to contribute to clinical trials through statistical expertise, ensuring quality and consistency in study designs and analyses.",[2813,2814,2797,2832],"Flexible remote work arrangement","https://boards.greenhouse.io/clinchoice/jobs/4527240101?utm_source=remoteliz.com","2025-01-31T05:38:07.611825-05:00",{"_855":2836,"_2041":2042,"_2043":2837,"_2045":89,"_2046":2838,"_2054":2839,"_13":2840,"_2062":2063,"_2064":2841,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2842,"_2086":2843,"_2088":2844,"_2090":2845,"_2092":2846,"_2098":2849,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2850,"_2105":2042},456,"Clinical Scientist Consultant - Established Products",{"_16":89,"_18":2129,"_20":2129,"_22":-5,"_2049":2019,"_2050":-5,"_2051":2052,"_2053":2018},[],[],"2025-01-28T09:58:13.896113-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Scientist Consultant- Established Products to join one of our clients.

Main Job Tasks and Responsibilities:

The Clinical Scientist, Established Products (CS-EP), is involved in supporting Compound Development Team Leaders and Clinical Leaders in the lifecycle management of a variety of marketed products across 4 Therapeutic Portfolios consisting of Internal Medicine/Infectious Diseases, Immunology & Cardiopulmonary, Neuroscience, and Oncology. The CS-EP position is dedicated to maximizing the value of the Therapeutic Portfolios by providing active scientific contribution to cross-functional clinical teams to enable worldwide registrations for new indications and enhancements to product labels.

Supports Clinical Teams in the fulfillment of clinical trials and projects as required by Health Authorities worldwide.
Assists Clinical Leaders in executing clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications.
Participates in cross-functional teams for evaluation of new product ideas, reviews medical literature and related new technologies.
Collaborates with internal stakeholders on providing support for interactions with internal and external experts/thought leaders and oversight of Investigator Initiated Studies.
Partners with Clinical Leaders, Global Labeling Teams, Regulatory Affairs and Safety to update the Core Data Sheets, EU, US and other local labels for products within the EP Therapeutic Portfolios.
Performs tasks in assisting Clinical Leaders with preparation of clinical study reports; submission dossiers; responses to requests from Health Authorities worldwide; registration studies conducted by operating companies; and timely implementations of corrective actions as needed.
Other duties will be assigned by Compound Development Team Leaders and Clinical Leaders, as appropriate, such as reviewing Confidential Company Information (CCI) and Yale University Open Data Access (YODA) requests.

Education and Experience:

MS, MPH, PharmD, PhD or equivalent clinical training/experience required.
A minimum of 3 years’ experience working in clinical research in academia or the pharmaceutical industry.
Excellent analytical, investigational, and organizational skills.
Cross-functional experience in complex projects.
Good interpersonal skills to interact with key team members and extract needed information.
Experience using clinical trials applications, such as v-Trial Master File, Madidate, and Interactive Web Response System

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research, Clinical, analytical, investigational, and organizational skills.

#LI-PB1

#LI-Remote

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ('PIPEDA') , personal information is collected under the authority of the Act and will only be used for candidate selection.

","At ClinChoice, we are seeking a Clinical Scientist Consultant - Established Products to support the lifecycle management of marketed products across various therapeutic portfolios. This role involves collaborating with cross-functional teams to maximize portfolio value, contributing to clinical studies and regulatory submissions, and maintaining high-quality standards in clinical research. We offer a supportive culture, professional development opportunities, and flexible work options.","Support the lifecycle management of marketed products by providing scientific contributions to cross-functional clinical teams at ClinChoice, a global CRO dedicated to accelerating drug development.",[2120,2847,2848,2121],"professional development opportunities","supportive culture","https://boards.greenhouse.io/clinchoice/jobs/4525216101?utm_source=remoteliz.com","2025-01-28T10:38:27.651424-05:00",{"_855":2852,"_2041":2042,"_2043":2853,"_2045":121,"_2046":2854,"_2054":2856,"_13":2857,"_2062":2063,"_2064":2859,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2860,"_2086":2861,"_2088":2862,"_2090":2863,"_2092":2864,"_2098":2868,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2869,"_2105":2042},5002,"Clinical Data Transformation Lead",{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},"2025-01-16T10:29:52.045255-05:00",[],[2858],{"_16":345,"_18":346,"_20":347,"_22":-5,"_23":348,"_25":349,"_27":350,"_29":351,"_31":-5},"2025-02-03T03:08:24.890715-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Data Transformation Lead to join one of our clients.

SUMMARY The role involves being a Clinical Data Transformation Lead in the Clinical Data Management area, focusing on enhancing data review and cleaning processes with innovative reports. It entails creating and implementing study specific data validation procedures and reports, managing the connection to varied data sources, and ensuring efficient scheduling, monitoring, and maintenance on the Clinical Data platform. The role requires detailing key da handling requirements for scalable data management methods, and deriving study-specific monitoring and validating reports based on clinical protocols and amendments. Ultimately, this position aims to advance clinical data management and informatics by improving data integrity, efficiency, and capacity for expansion.

RESPONSIBILITIES • Engage closely with Global Development business units such as BDM, Safety, Precision Medicine, Pharmacometrics, Digital Health etc. to deeply understand data quality, monitoring and validation needs and transform these insights into detailed business requirements for clinical data products. • Act as the primary point of accountability, responsibility, and expertise in interpreting Clinical Data business needs, meticulously translating and documenting these into comprehensive business specifications at the segment, modality, and company-wide levels. • Demonstrates a business understanding of study specific data to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e., ensuring consistency across data quality plans. • Thoroughly document the clinical product development process, including data sources, methodologies, algorithms, and underlying assumptions, to guarantee transparency, reproducibility, and auditability of clinical data products. • Craft study-specific Data Quality specifications and define key Clinical data metrics to uphold the highest data quality and integrity standards across study lifecycles. • Prepare study-level reports within the Clinical Data Platform to support stakeholder activities and ensure the effective use of clinical study data. • Query small to large clinical data sets, manage data ingestion and delivery specifications, and data modeling requirements. analyzes and evaluates clinical data, recognizes inconsistencies, and initiates the resolution of da problems. • Design clear, concise requirements for clinical reports and dashboards, establishing relevant metrics to convey data-driven insights effectively. Present findings in a compelling manner, customized for key clinical business functions such as Clinical Data Management, Pharmacometrics, etc. • Work towards preparing Common Data Model mapping & transformations to ensure data is usable in the analytical layer/ and comply with the Governance Committee strategy.

QUALIFICATION

• Have a bachelor’s degree in computer science, Data Science, Statistics, or a similar area is required. Candidate should have substantial experience, ideally over 7 years, specifically within clinical data analysis and preferably within the BioPharma sector. • Have hands-on experience with various clinical datasets such as EDC and non-crf dat combined with strong analytical abilities capable of managing diverse, large, and complex datasets, which ranges from fundamental research collections to detailed clinical information. • Possess a deep understanding of modern data analytic frameworks and technology, which includes expertise in Big Data structures, Lakehouse architectures, as well as contemporary techniques for data collection and amalgamation. • Have full understanding of clinical trial process. • Have a passion for championing and implementing clinical data platform. • Should have practical experience with ETL processes, programming languages such a SQL, Python, R, and familiarity with the AWS cloud infrastructure, including S3, Dat Lake, along with analytics realms • Have strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. • Possess Excellent communication, and project management skills.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ('PIPEDA') , personal information is collected under the authority of the Act and will only be used for candidate selection.

#LI-TT1 #LI-Remote #Senior #Contract

","At ClinChoice, we are seeking a Clinical Data Transformation Lead to enhance data review and cleaning processes. The role involves creating study-specific validation procedures, managing data sources, and improving clinical data management efficiency. You will work closely with various business units to translate insights into detailed requirements for clinical data products. This position requires hands-on experience with clinical datasets, strong analytical skills, and expertise in modern data frameworks.","Lead the transformation of clinical data processes at ClinChoice, enhancing data integrity and efficiency through innovative reporting and validation procedures.",[2865,2094,2866,2867],"Flexible Work Options","Supportive Culture","Global Career Opportunities","https://boards.greenhouse.io/clinchoice/jobs/4529018101?utm_source=remoteliz.com","2025-02-03T03:27:04.687505-05:00",{"_855":2871,"_2041":2042,"_2043":2267,"_2045":121,"_2046":2872,"_2054":2873,"_13":2875,"_2062":2063,"_2064":2877,"_2066":2063,"_2067":2068,"_2069":2070,"_2071":2878,"_2073":2072,"_2075":2076,"_2077":2078,"_2003":2879,"_2086":2880,"_2088":2881,"_2090":2882,"_2092":2883,"_2098":2888,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2889,"_2105":2042},4874,{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[2874],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2876],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-01T03:26:40.472137-05:00",75000,{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a number of dynamic people to join our in-house team as a Senior Clinical Research Associate (Senior CRA) on a permanent basis. You will be responsible for 2-3 trials and conducting site management (including start-up), both on-site and remotely, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Applicants must have experience monitoring oncology and/or respiratory clinical trials.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
May act as Feasibility Associate.
Train site staff in all study procedures.
Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
Act as the main contact person for the site in order to ensure close follow up.
Provide general support to the Clinical Research Division on quality control of clinical data.
Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.
Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
Develop training material and give training in collaboration with the Training & Qualification Management Unit.
May assist with contract negotiation with sites on study budget after appropriate training.
Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.
May support the submission process in the project including submission requirements, timelines, informed consent development, etc..
Guide and supervise Clinical Research Associate I (CRA I) in order to coach and train them on the job.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
Proven experience as a CRA, performing on-site monitoring activities.
Experience with oncology or respiratory trials is required.
Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research Associate, CRA, Site Management, Site Manager, Monitor, Monitoring, Oncology, Respiratory, Travel, Submissions, Ethics, CRO, Contract Research Organisation

#LI-VH1

","At ClinChoice, we are a global full-service CRO dedicated to accelerating the development of innovative drugs and devices. We are seeking a Senior Clinical Research Associate (Senior CRA) to join our team on a permanent basis. In this role, you will manage 2-3 clinical trials, conduct site management both on-site and remotely, and work with clients ranging from small biotechs to large pharmaceutical companies. Key responsibilities include monitoring oncology and respiratory trials, training site staff, conducting source data verification, managing investigational products, ensuring proper safety reporting, and providing support in contract negotiations and study submissions. We offer professional development opportunities, a supportive 'one-team' culture, and the chance to make a meaningful impact on global healthcare.","Join ClinChoice as a Senior CRA and contribute to clinical research excellence by managing trials, conducting site visits, ensuring regulatory compliance, and fostering collaboration with sites and clients across various therapeutic areas including oncology and respiratory. This role offers professional growth and the opportunity to work in a dynamic, quality-focused environment.",[2884,2885,2886,2887],"Professional development opportunities","Excellent work-life balance","Quality-focused collaborative culture","Travel stipend or allowance","https://boards.greenhouse.io/clinchoice/jobs/4527467101?utm_source=remoteliz.com","2025-02-02T05:25:45.387315-05:00",{"_855":2891,"_2041":2042,"_2043":2853,"_2045":121,"_2046":2892,"_2054":2893,"_13":2894,"_2062":2063,"_2064":2896,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2897,"_2086":2898,"_2088":2899,"_2090":2900,"_2092":2901,"_2098":2903,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2904,"_2105":2042},4830,{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[],[2895],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-01T03:25:16.14573-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Data Transformation Lead to join one of our clients.

SUMMARY The role involves being a Clinical Data Transformation Lead in the Clinical Data Management area, focusing on enhancing data review and cleaning processes with innovative reports. It entails creating and implementing study specific data validation procedures and reports, managing the connection to varied data sources, and ensuring efficient scheduling, monitoring, and maintenance on the Clinical Data platform. The role requires detailing key da handling requirements for scalable data management methods, and deriving study-specific monitoring and validati reports based on clinical protocols and amendments. Ultimately, this position aims to advance clinical data management and informatics by improving data integrity, efficiency, and capacity for expansion.

QUALIFICATION

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-TT1 #LI-Remote #Senior #Contract

","At ClinChoice, we are seeking a Clinical Data Transformation Lead to enhance data review and cleaning processes. The role involves creating and implementing study-specific validation procedures, managing data sources, and ensuring efficient scheduling on the Clinical Data platform. You will work closely with various business units to translate insights into detailed requirements for clinical data products. This position requires expertise in handling large datasets, modern analytic frameworks, and strong communication skills.","Enhance clinical data management by improving data integrity and efficiency as a Clinical Data Transformation Lead at ClinChoice. Work with diverse teams to develop innovative solutions and contribute to the advancement of clinical informatics.",[2867,2902,2866,2865],"Professional Development","https://boards.greenhouse.io/clinchoice/jobs/4528224101?utm_source=remoteliz.com","2025-02-02T05:32:38.743387-05:00",{"_855":2906,"_2041":2042,"_2043":2785,"_2045":121,"_2046":2907,"_2054":2908,"_13":2909,"_2062":2063,"_2064":2911,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2912,"_2086":2913,"_2088":2914,"_2090":2915,"_2092":2916,"_2098":2919,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2920,"_2105":2042},4829,{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[],[2910],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-02-01T03:25:14.856859-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Data Acquisition and Strategy Manager to join one of our clients.

SUMMARY

RESPONSIBILITIES

QUALIFICATION

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-TT1 #LI-Remote #Senior #Contract

","At ClinChoice, we are seeking a Clinical Data Acquisition and Strategy Manager to lead the participant data journey. This role involves defining data sources, ensuring data integrity, collaborating with technical and clinical teams, and providing strategic solutions for data management. The ideal candidate will have strong knowledge of modern data technologies and experience in handling complex clinical datasets. Join us in contributing to a healthier world by accelerating innovative drug development.","Lead the participant data journey at ClinChoice, ensuring data integrity and collaborating with cross-functional teams to provide strategic solutions for clinical data management.",[2917,2866,2918,2865],"Career Development Opportunities","Global Work Environment","https://boards.greenhouse.io/clinchoice/jobs/4528222101?utm_source=remoteliz.com","2025-02-02T05:32:44.200777-05:00",{"_855":2922,"_2041":2042,"_2043":2923,"_2045":121,"_2046":2924,"_2054":2925,"_13":2927,"_2062":2063,"_2064":2929,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2930,"_2086":2931,"_2088":2932,"_2090":2933,"_2092":2934,"_2098":2936,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2937,"_2105":2042},4787,"Senior Clinical Research Associate - Oncology",{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[2926],{"_16":17,"_18":2057,"_20":2057,"_22":-5,"_23":2058,"_25":2059,"_31":-5},[2928],{"_16":1897,"_18":1898,"_20":1899,"_22":-5,"_23":1900,"_25":1901,"_27":1902,"_29":1903,"_31":-5},"2025-02-01T03:23:27.995529-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for two dynamic professionals to join our in-house team as a Senior Clinical Research Associate (Senior CRA) on a permanent basis. You will be working on 2-3 trials, where you will be responsible for site management (including start-up), both on-site and remotely, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Previous experience monitoring oncology and/or respiratory clinical trials is required.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
May act as Feasibility Associate.
Train site staff in all study procedures.
Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
Act as the main contact person for the site in order to ensure close follow up.
Provide general support to the Clinical Research Division on quality control of clinical data.
Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.
Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
Develop training material and give training in collaboration with the Training & Qualification Management Unit.
May assist with contract negotiation with sites on study budget after appropriate training.
Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.
May support the submission process in the project including submission requirements, timelines, informed consent development, etc..
Guide and supervise Clinical Research Associate I (CRA I) in order to coach and train them on the job.

Education, Experience and Skills:

University Degree in scientific, medical or paramedical disciplines.
Proven experience as a CRA, performing on-site monitoring activities.
Experience with oncology or respiratory trials is required.
Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Fluent in English and local language(s).
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
Willingness to travel.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-LG1

","ClinChoice is seeking a Senior Clinical Research Associate (Senior CRA) to join their in-house team. The role involves managing 2-3 clinical trials, handling site management both on-site and remotely, and working with diverse clients across pharmaceuticals, biotechnology, medical devices, and consumer health. Key responsibilities include site selection, training staff, conducting monitoring visits, ensuring data quality, managing investigational products, overseeing safety reporting, and collaborating with team members to ensure project success. The ideal candidate must have a university degree in a relevant field, proven experience as a CRA, especially in oncology or respiratory trials, strong knowledge of GCP/ICH Guidelines, fluency in English and local languages, proficiency in Microsoft Office, and willingness to travel. ClinChoice offers professional development opportunities, excellent work-life balance, and a collaborative culture.","Join ClinChoice as a Senior CRA and contribute to clinical trial management, ensuring high-quality data and compliance with regulations while working on impactful projects across various therapeutic areas.",[2884,2885,2935],"Collaborative team culture","https://boards.greenhouse.io/clinchoice/jobs/4528671101?utm_source=remoteliz.com","2025-02-02T05:39:12.739673-05:00",{"_855":2939,"_2041":2042,"_2043":2940,"_2045":121,"_2046":2941,"_2054":2942,"_13":2943,"_2062":2063,"_2064":2945,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2946,"_2086":2947,"_2088":2948,"_2090":2949,"_2092":2950,"_2098":2951,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2952,"_2105":2042},4320,"Global Labeling Lead Consultant",{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[],[2944],{"_16":1905,"_18":1906,"_20":1907,"_22":-5,"_23":1908,"_25":1909,"_27":1910,"_29":1911,"_31":-5},"2025-01-28T13:15:44.714877-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Global Labeling Lead Consultant with REMOTE option in US, to join one of our major pharmaceutical clients.

DUTIES & RESPONSIBILITIES:

As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects. You will be responsible for driving strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies and will raise awareness of key factors to consider when revising labels. The GLL will ensure that the impact on Country Labeling Documents is considered during labeling discussions and will advise the labeling team on the content of other labels in the same therapeutic class. You will play a crucial role in ensuring compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.

Key Responsibilities:

Provide strategic support and leadership to the labeling team, providing guidance, coaching, and feedback. Guide the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and their associates patient labeling documents. Keep up-to-date with labeling guidelines and regulations related to the development and maintenance of US and EU labeling. Provide project management to the labeling team throughout the process from request to stakeholder notification. Set clear target and prioritization plans, ensuring that labeling teams are aware of the require timelines so that deliverable remain on target to team internal and external deadlines. Act as the primary point of contact for the labeling team members and provide day-to-day direction to Labeling Operations Managers so labeling can be prepared and managed appropriately. Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines, and company policies and procedures. Ensure adherence to relevant regulatory guidelines, such as FDA, EMA, and ICH, throughout the labeling process. Collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Manufacturing, to ensure smooth and timely execution of labeling activities. Monitor industry trends and regulatory changes related to pharmaceutical labeling, and proactively implement necessary updates and improvements to labeling processes. Collaborate with clients and provide expert advice and guidance on labeling requirements, best practices, and compliance matters. Produces quality work that meets or exceeds client expectations. Contribute to business strategy discussions and implement regional and global specific objectives, as appropriate. Lead strategic initiatives and develop implementation plans taking ownership for final results and implementing process improvements where needed. Participates in preparing written and presented bid developments for new clients. Identify opportunities for business growth to ensure on going client support and positive engagement Prepare and present client metrics as needed. Train and provide guidance to other GLLs as needed.

Experience & Qualifications:

Bachelor's degree in a scientific or related field. Advanced degree (Masters, PhD) is a plus. Minimum 7 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting. Strong knowledge of regulatory requirements and guidelines related to pharmaceutical labeling, including FDA, EMA, and ICH guidelines. Demonstrated knowledge and understanding of CCDS and the labeling team purpose and objectives. Ability to liaise with stakeholders. Excellent project management skills, with the ability to prioritize tasks, manage timelines, and handle multiple projects simultaneously. Strong attention to detail and accuracy, with a focus on delivering high-quality labeling solutions. Effective leadership and team management abilities, with excellent communication and interpersonal skills. Proven problem-solving skills and the ability to make sound decisions under pressure. Demonstrated ability to manage regulatory activities and deliver against project timelines. Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint). Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

#LI-PR1 #LI-Remote #Contract

","ClinChoice is seeking a Global Labeling Lead Consultant to work remotely in the US. The role involves providing strategic support and leadership to the labeling team, ensuring compliance with regulatory requirements, and delivering high-quality labeling solutions for pharmaceutical clients. Key responsibilities include managing labeling documents, collaborating with cross-functional teams, and staying updated on industry trends and regulations. Candidates must have a bachelor's degree, minimum 7 years of experience in pharmaceutical labeling, strong knowledge of FDA, EMA, and ICH guidelines, excellent project management skills, and proficiency in Microsoft Office Suite.","Lead the development and maintenance of labeling documents for pharmaceutical clients while ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to deliver high-quality solutions at ClinChoice.",[2865,2094,2866],"https://boards.greenhouse.io/clinchoice/jobs/4368655101?utm_source=remoteliz.com","2025-01-28T14:11:48.47412-05:00",{"_855":2954,"_2041":2042,"_2043":2802,"_2045":121,"_2046":2955,"_2054":2956,"_13":2957,"_2062":2063,"_2064":2959,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2960,"_2086":2961,"_2088":2962,"_2090":2963,"_2092":2964,"_2098":2967,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2968,"_2105":2042},4215,{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[],[2958],{"_16":625,"_18":626,"_20":627,"_22":-5,"_23":628,"_25":629,"_27":630,"_29":631,"_31":-5},"2025-01-28T13:10:50.753813-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Freelance Clinical Research Associate for 0.5 FTE. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Join our team and help us deliver clinical trials that will improve patients' lives.

Main Job Tasks and Responsibilities:

Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
May act as Feasibility Associate after appropriate and documented training.
Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance.
Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety.
Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data.
Manages the investigational products (storage, inventory, dispensing records, packaging, and labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
You will be the main contact person for the site in order to ensure close follow up.
Provides general support to the Clinical Research Division on quality control of clinical data.
Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned.
Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
Develops training material and gives training in collaboration with the Training & Qualification Management Unit.
May assist in contract negotiation with sites on study budget after appropriate and documented training.
Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites.
May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.

Education and Experience:

University Degree in scientific medical or paramedical disciplines.
Previous proven experience as a CRA, performing on-site monitoring activities.
Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirement.

Specific Role Requirements and Skills:

Fluent in English and French
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
Willingness to travel

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Keywords: Senior Clinical Research Associate, Senior CRA, Site Management, Monitor, Monitoring, Oncology, Respiratory, Medical Device, Cardiology, Travel, Submissions, Ethics, Contract Research Organisation, CRO, Permanent

#LI-CM1 #LI-REMOTE #SENIOR #FULLTIME

","ClinChoice is seeking a Freelance Clinical Research Associate to join their in-house team. The role involves supporting clinical trials across various clients, ensuring compliance with GCP/ICH guidelines and regulatory requirements. Key responsibilities include site selection, monitoring visits, data management, training site staff, and maintaining quality control of clinical data. The position requires strong communication skills, proficiency in Microsoft Office, fluency in English and French, and the ability to travel. ClinChoice offers a collaborative work environment with opportunities for professional development.","Join ClinChoice as a Freelance Clinical Research Associate to support clinical trials, ensuring compliance with GCP/ICH guidelines. Work on diverse projects across pharmaceutical, biotech, medical device, and consumer health companies. Collaborate with a dedicated team in a quality-focused culture while enjoying professional growth opportunities.",[2884,2885,2965,2966],"Collaborative 'one-team' culture","Quality-focused environment","https://boards.greenhouse.io/clinchoice/jobs/4500742101?utm_source=remoteliz.com","2025-01-29T05:56:42.657831-05:00",{"_855":2970,"_2041":2042,"_2043":2837,"_2045":121,"_2046":2971,"_2054":2972,"_13":2973,"_2062":2063,"_2064":2974,"_2066":2063,"_2067":2068,"_2069":2010,"_2071":2114,"_2073":2114,"_2075":2076,"_2077":2078,"_2003":2975,"_2086":2976,"_2088":2977,"_2090":2978,"_2092":2979,"_2098":2982,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":2983,"_2105":2042},453,{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[],[],"2025-01-28T09:58:04.315973-05:00",{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Clinical Scientist Consultant- Established Products to join one of our clients.

Main Job Tasks and Responsibilities:

Supports Clinical Teams in the fulfillment of clinical trials and projects as required by Health Authorities worldwide.
Assists Clinical Leaders in executing clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications.
Participates in cross-functional teams for evaluation of new product ideas, reviews medical literature and related new technologies.
Collaborates with internal stakeholders on providing support for interactions with internal and external experts/thought leaders and oversight of Investigator Initiated Studies.
Partners with Clinical Leaders, Global Labeling Teams, Regulatory Affairs and Safety to update the Core Data Sheets, EU, US and other local labels for products within the EP Therapeutic Portfolios.
Performs tasks in assisting Clinical Leaders with preparation of clinical study reports; submission dossiers; responses to requests from Health Authorities worldwide; registration studies conducted by operating companies; and timely implementations of corrective actions as needed.
Other duties will be assigned by Compound Development Team Leaders and Clinical Leaders, as appropriate, such as reviewing Confidential Company Information (CCI) and Yale University Open Data Access (YODA) requests.

Education and Experience:

MS, MPH, PharmD, PhD or equivalent clinical training/experience required.
A minimum of 3 years’ experience working in clinical research in academia or the pharmaceutical industry.
Excellent analytical, investigational, and organizational skills.
Cross-functional experience in complex projects.
Good interpersonal skills to interact with key team members and extract needed information.
Experience using clinical trials applications, such as v-Trial Master File, Madidate, and Interactive Web Response System

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Clinical Research, Clinical, analytical, investigational, and organizational skills.

#LI-PB1

#LI-Remote

","Join ClinChoice as a Clinical Scientist Consultant - Established Products. Work with cross-functional teams to support clinical trials and maximize product portfolio value across various therapeutic areas. Gain experience in new indications, post-approval commitments, and label updates while collaborating with global experts and regulatory affairs. Enjoy professional development opportunities within a supportive environment at a leading CRO.","Support clinical teams in maximizing the value of therapeutic portfolios by contributing to cross-functional projects, clinical trials, and regulatory submissions. Collaborate with internal and external stakeholders to advance product registrations and maintain high-quality standards.",[2980,2797,2814,2981],"Global CRO opportunities","Flexible work arrangements","https://boards.greenhouse.io/clinchoice/jobs/4525214101?utm_source=remoteliz.com","2025-01-28T10:39:32.993944-05:00",{"_855":2985,"_2041":2042,"_2043":2108,"_2045":121,"_2046":2986,"_2054":2987,"_13":2988,"_2062":2063,"_2064":2989,"_2066":2063,"_2067":2068,"_2069":2070,"_2071":2990,"_2073":2072,"_2075":2076,"_2077":2078,"_2003":2991,"_2086":2992,"_2088":2993,"_2090":2994,"_2092":2995,"_2098":3000,"_2100":-5,"_2101":2010,"_2102":2010,"_2103":2010,"_20":3001,"_2105":2042},452,{"_16":121,"_18":2855,"_20":2855,"_22":-5,"_2049":2023,"_2050":-5,"_2051":2052,"_2053":2022},[],[],"2025-01-28T09:58:02.977219-05:00",70000,{"_855":2078,"_2041":2080,"_23":2005,"_25":2006,"_2007":2008,"_2009":2010,"_2011":2010,"_2012":2010,"_2081":2082,"_2050":-5,"_2013":-5,"_2083":2037,"_2084":2063,"_2085":2010},"

ClinChoice is searching for a Program Coordinator Consultant to join one of our clients.

Main Job Tasks and Responsibilities:

Create and maintain integrated cross functional project plans, forecast and demand projections, and scenario plans in Planisware.
Create, maintain, and distribute scope control reports.
Provide tracking and reporting of EP Metrics.
Collaborate with cross functional team members in the Project Management Team.
Engage in cross organizational partnerships and collaboration with key business partners.
Participate in continuous process improvement initiatives.

Provide coordination support to the Project Management and Clinical functional teams assigned to ensure completion of deliverables that are balanced for quality, timelines and resources.
Create and maintain cross functional project plans and team reports and provide resource management support to ensure the completion of deliverables balanced for quality and timeliness.
Schedule and maintain regulatory filing, approval, and launch strategy related milestones.
Facilitate critical path analysis and optimization planning. Assist team in determining schedule and resource requirements.
Build, maintain and share key event maps from Planisware.
Assist the Program Manager in providing short term and long-range planning, resource, forecast and demand management support to the Compound Development Teams (CDTs).
Facilitate team communications by maintaining and tracking cross-functional timeliness, deliverables, and milestones including cross project dependencies.
Generate program reports and communications to ensure team and program alignment of deliverable expectations.
Assist functions in determining schedule and resource requirements.
Conduct contingency planning and scenario analyses and propose opportunities to accelerate planning and optimize resource allocation.
Conduct scope control analyses from a planning and forecasting perspective and translate the data to insights in reports.
Identify continuous process improvement opportunities concerning the planning and forecasting environment.

Education and Experience:

A bachelor’s degree in scientific or business management discipline is required; a post-graduate degree is preferred.
Commanding knowledge of and experience with MS Project, Planisware, or similar planning tool, is required.
Knowledge of and experience with pharmaceutical product development, clinical development, and lifecycle management is required.
Hands on experience with extracting knowledge and insights from structured and unstructured data is preferred. This may include design thinking, robotic process automation, generative artificial intelligence, data mining, visualization, predictive analytics, and/or big data analytics.
Clear and transparent communication, organization, self-awareness, interdependent partnering and collaboration, and stakeholder management are required skills and abilities.
Previous experience with working in a global matrix organization with cross functional teams and cross organizational business partners is preferred.
Experience with process excellence is preferred.
Management Professional (PMP) or another project management certification is preferred.
Planisware and Microsoft Project.
PMP certification

The Application Process

Who will you be working for?

About ClinChoice

Our Company Ethos

Key words: Plainsware, MS Project, Lifecycle Management, PMP

#LI-PB1

#LI-Remote

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ('PIPEDA') , personal information is collected under the authority of the Act and will only be used for candidate selection.

","ClinChoice is seeking a Program Coordinator Consultant to work directly with clients while benefiting from the security and opportunities of a global CRO. The role involves creating and maintaining project plans, collaborating with cross-functional teams, and supporting program management activities. Key responsibilities include using tools like Planisware and MS Project, conducting critical path analysis, and providing resource management support. Candidates should have a bachelor's degree in a relevant field, experience with project planning tools, knowledge of pharmaceutical development, and strong communication skills. Professional certifications such as PMP are preferred. This role offers professional growth opportunities within a supportive global organization.","Join ClinChoice as a Program Coordinator Consultant to support program management activities using Planisware and MS Project while collaborating with cross-functional teams in a global CRO environment.",[2813,2996,2997,2998,2999],"Professional development support","Supportive work culture","Flexible working arrangements","Competitive salary and benefits package","https://boards.greenhouse.io/clinchoice/jobs/4525220101?utm_source=remoteliz.com","2025-01-28T10:39:39.437745-05:00","organizationSchema",{"_3004":3005,"_3006":3007,"_23":2005,"_2009":2010,"_2007":2008,"_2011":2010,"_3008":3009},"@context","https://schema.org","@type","Organization","numberOfEmployees",{"_3006":3010,"_3011":2033,"_3012":2035},"QuantitativeValue","minValue","maxValue","breadcrumbSchema",{"_3004":3005,"_3006":3015,"_3016":3017},"BreadcrumbList","itemListElement",[3018,3024,3027],{"_3006":3019,"_3020":17,"_23":3021,"_3022":3023},"ListItem","position","Home","item","http://www.remoteliz.com",{"_3006":3019,"_3020":33,"_23":3025,"_3022":3026},"Companies","https://www.remoteliz.com/remote-companies",{"_3006":3019,"_3020":41,"_23":2005,"_3022":3028},"http://www.remoteliz.com/remote-companies/clinchoice","routes/remote-companies.$slug","actionData","errors"]

ClinChoice Overview

ClinChoice

Open Positions

Business Development Director

Program Coordinator Consultant

Principal Statistical Programmer – Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)

Clinical Project Manager II

Principal Statistician– Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)

Medical Information Call Center Consultant (MICC Consultant)

Clinical Data Management Lead Consultant - (AD/DIR Level)(REMOTE - Long Term Contract)

Senior Statistician Consultant- Late Phase Oncology (Remote in EU/UK)

Safety Medical Reviewer Consultant

Senior Clinical Research Associate - Oncology/Respiratory

Clinical Trial Administrator

Clinical Project Director

Project Director, Clinical Operations - Respiratory

Executive-Medical Device Technical Writing Consultant

Clinical Project Manager II

Director of Business Development

Senior Regulatory Affairs Specialist Consultant - OTC products

Senior PKPD Programmer Consultant (remote in US)

Director of Business Development

Project Director, Clinical Operations - Oncology

Safety Medical Reviewer Consultant– Immunology

Senior Clinical Project Manager

Senior STDM Statistical Programmer Consultant (Remote)

Safety Medical Reviewer Consultant– Immunology

Project Manager I or II

Freelance Clinical Research Associate (CRA) - Medical Device

Client Success Manager

Statistical Programmer/Analyst III- Permanent Role

Clinical Project Manager II

Senior Clinical Project Manager - Oncology/Respiratory

Senior Clinical Project Manager - Oncology/Respiratory

Clinical Research Department Director

Clinical Research Department Director

Clinical Research Department Director

Associate Director/Director - Biostatistics consultant (Inflammatory and Immune diseases)

Clinical Data Acquisition and Strategy Manager

Clinical Research Associate

Senior Statistician

Clinical Scientist Consultant - Established Products

Clinical Data Transformation Lead

Senior Clinical Research Associate - Oncology/Respiratory

Clinical Data Transformation Lead

Clinical Data Acquisition and Strategy Manager

Senior Clinical Research Associate - Oncology

Global Labeling Lead Consultant

Clinical Research Associate

Clinical Scientist Consultant - Established Products

Program Coordinator Consultant