Senior Manager, Clinical Data Management
Core
Lead end-to-end clinical data management for complex drug development trials, ensuring data quality, compliance, and timely delivery of submission-ready datasets.
Role type
Senior Manager, Clinical Data Management
Builds
Clean, submission-ready clinical datasets for regulatory filings (NDA, BLA, MAA)
Domain
Pharmaceutical R&D / Clinical Trials
Required skills
Clinical drug development processes, FDA/ICH guidelines, EDC systems, Project management, Metrics analysis, Vendor oversight, Regulatory submission requirements
Preferred skills
Medidata RAVE, PMP certification, Advanced degree
Technologies
EDC platforms, eCOA, Safety Gateway
Responsibilities
Drive data collection strategy across complex projects, Own the full data management lifecycle, Chair Data Quality Review meetings, Author and review key study documents, Mentor junior Data Management Leads, Oversee vendors and CROs
Seniority
Senior Manager, hands-on leadership
