Senior Manager, Clinical Data Management

About the role

Regeneron is seeking a Senior Manager to lead Clinical Data Management activities across multiple studies, from start‑up through archiving. The role is remote within the United States and focuses on delivering high‑quality data outputs while ensuring regulatory compliance and inspection readiness.

Key responsibilities

• Lead data management activities for clinical studies, overseeing start‑up, data collection, cleaning, and database lock.
• Serve as the primary contact for study teams, CROs, and external data vendors.
• Manage data quality review, acceptance, and database lock processes.
• Oversee data transfers, coding, and reconciliation across systems, including eTMF documentation.
• Review and approve study documentation such as data plans and specifications.
• Ensure inspection readiness and maintain compliant documentation in the electronic trial master file.
• Collaborate effectively with cross‑functional and external teams while prioritizing multiple activities.

Required profile

• Bachelor’s degree in Mathematics, Science, or a related field.
• Minimum 8 + years of clinical data management experience in the pharmaceutical or biotech industry.
• Demonstrated knowledge of 21 CFR Part 11 and ICH‑GCP regulations.
• Certified Clinical Data Manager (CCDM) certification preferred.
• Proven experience leading study teams and managing people.

Required skills

• Clinical data management processes and standards.
• eTMF (electronic trial master file) systems.
• Regulatory compliance (21 CFR Part 11, ICH‑GCP).

What we offer

• Inclusive culture with comprehensive health, wellness, and retirement benefits.
• Equity awards, annual bonuses, and paid time off.
• Opportunities for professional growth within a science‑driven organization.