Associate Director, Clinical Data Management
Core
Lead clinical data management for complex biopharma development projects, ensuring high-quality data collection and delivery for regulatory submissions.
Role type
Senior IC clinical data management lead (Associate Director)
Builds
Clinical trial data sets for New Drug Applications (NDA) and Biologics License Applications (BLA)
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical drug development process, FDA/ICH guidelines, EDC systems (Medidata RAVE), project management, metrics analysis, regulatory submission requirements
Preferred skills
Advanced degree in life sciences/data science/statistics, study/program leadership experience
Technologies
Medidata RAVE, Microsoft Office
Responsibilities
Provide clinical data management leadership to align on data collection requirements; Plan and deliver complete, high-quality clinical trial data; Author and review DM study plans and quality management documents; Chair data quality review meetings; Lead or support Health Authority inspections and audits; Provide oversight of third-party vendors and CROs; Coach junior Data Management Leads.
Seniority
Senior, hands-on IC with leadership responsibilities
