Clinical Data Manager
Core
Senior Clinical Data Manager responsible for managing the full lifecycle of clinical trial data from study startup to database lock, ensuring high-quality data delivery for innovative therapies.
Role type
Senior IC Clinical Data Manager
Builds
Clinical databases and data management documentation for clinical trials
Domain
Clinical research / Drug development
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical trial data management, Database development and testing, CRF specification development, Data entry process oversight, Quality control of data entry, Edit check specification, Trial Master File documentation, Medical coding, SAE/AE reconciliation, Vendor management, SAS programming support, Protocol/SAP/CSR review
Preferred skills
MedDRA and WHODrug coding, CDISC standards (CDASH, SDTM, ADaM), Oncology experience, Orphan Drug experience
Technologies
EDC systems, Microsoft Office, SAS
Responsibilities
Lead data management for assigned projects, Develop and maintain data management documentation, Train clinical research personnel, Coordinate with third-party vendors, Troubleshoot operational issues, Present software demonstrations
Seniority
Senior, hands-on IC with leadership responsibilities