Lead Clinical Data Manager

Lead Clinical Data Manager

This role sits at the core of clinical trial execution, ensuring that high-quality, reliable data supports the development of next-generation cell therapies. You will oversee end-to-end clinical data management activities from study start-up through database lock and study close, working across EDC systems, non-EDC data sources, and cross-functional clinical teams. The position plays a critical role in ensuring data accuracy, consistency, and regulatory compliance in a highly regulated biotech environment. You will be responsible for building and maintaining robust data management frameworks, supporting study execution, and enabling timely decision-making for clinical programs. The environment is fast-paced, mission-driven, and deeply rooted in scientific rigor and patient impact. This is an opportunity to contribute directly to advancing innovative therapies that aim to improve survival outcomes and transform patient lives.

Accountabilities:

• Lead all clinical data management activities across studies from start-up through database lock and study close, ensuring high-quality and timely delivery of clinical data.
• Design and maintain clinical trial documentation including CRFs, data management plans, edit check specifications, data review plans, and data transfer agreements.
• Build and manage EDC systems, including study setup, UAT, data validation, and ongoing maintenance to ensure optimal data collection and flow.
• Oversee data cleaning, query management, discrepancy resolution, and reconciliation of clinical data across multiple sources.
• Ensure compliance with regulatory standards including GCP, CDISC (SDTM/CDASH), ICH guidelines, and 21 CFR Part 11 requirements.
• Collaborate with clinical operations, biostatistics, and other stakeholders to resolve data issues, generate reports, and support study decision-making.

Requirements:

• 5–7+ years of clinical data management experience within pharmaceutical or biotechnology environments, ideally in sponsor-side or smaller biotech settings.
• Strong knowledge of clinical data standards including CDISC, SDTM, and CDASH, as well as regulatory frameworks such as ICH and GCDMP.
• Hands-on experience with EDC systems and clinical data management tools, including data validation, reconciliation, and database lock processes.
• Familiarity with medical coding dictionaries such as MedDRA and WHO Drug, and experience supporting data review and cleaning activities.
• Strong project management and stakeholder coordination skills, with the ability to manage multiple studies and competing priorities.
• Detail-oriented mindset with strong analytical skills and the ability to proactively identify and mitigate data quality risks.

Benefits:

• Competitive compensation package based on experience, education, and location
• Annual bonus eligibility and pre-IPO equity opportunities (for full-time employees)
• Comprehensive medical, dental, and vision insurance
• 401(k) retirement savings plan
• Paid time off and parental leave benefits
• Life, accident, and disability insurance coverage
• Remote flexibility depending on role requirements
• Opportunity to contribute to cutting-edge cell therapy innovation with high patient impact