Lead Clinical Data Manager in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead Clinical Data Manager based in the United States.

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.

• 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.

• 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.

• 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