Director, Clinical Data Management
Core
Lead end-to-end clinical data management strategy and execution for a new oncology radiopharmaceutical product from study start-up through database lock.
Role type
Director, Clinical Data Management (Program Lead)
Builds
Clinical trial data for oncology radiopharmaceutical therapies
Domain
Biotechnology / Oncology / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Data Management strategy, EDC systems (Medidata RAVE/Veeva), GCP/CDISC/CDASH/ICH/FDA regulations, CRO/vendor management, cross-functional alignment, data quality oversight, AI tool utilization
Preferred skills
Radiopharmaceutical experience
Technologies
Medidata RAVE, Veeva
Responsibilities
Develop and drive data management strategy for new-product programs, oversee CROs and vendors, partner cross-functionally with Biostatistics and Regulatory Affairs, lead cross-functional data review activities, oversee data management documentation
Seniority
Director, Program Leadership