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

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 Clinical Data Management Lead Consultant  to join one of our clients in Hematology TA Team. 

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.  

 

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

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.           

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 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.

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