Senior Manager, Clinical Data Management
Core
Lead clinical data management for complex development projects, ensuring high-quality data collection and delivery for innovative medicines.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical trial data deliverables for R&D pipeline
Domain
Biopharmaceuticals / Clinical Data Management
Required skills
Clinical drug development process knowledge, FDA/ICH guidelines, EDC systems (Medidata RAVE), project management, metrics analysis, data quality management, vendor oversight, study plan authoring
Preferred skills
Advanced degree, PMP certification
Technologies
Medidata RAVE, Microsoft Office, eCOA, Safety Gateway
Responsibilities
Align study teams on data collection requirements, plan and deliver trial data, oversee third-party vendors, enforce data standards, author study plans and quality documents, chair data quality review meetings, support health authority inspections, coach junior leads, manage data currency and SLAs, support CAPA implementation
Seniority
Senior, hands-on leadership with mentorship
