Lead Data Manager for Clinical Trials
Core
Lead all data management activities for large, complex clinical studies, serving as the primary communication point for project teams, clients, and vendors regarding data integrity and reporting.
Role type
Lead Data Manager for Clinical Trials
Builds
Final integrated clinical databases and Data Management deliverables for pharmaceutical and biotech clinical projects.
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management, EDC development, data collection, data cleaning, data reconciliation, database lock, study document review, Data Management plan development, user acceptance testing, Data Validation Plan creation, query generation and resolution, CRF design review, medical data coding, SAE reconciliation, electronic data transfer, document management (TMF/eTMF), database QC checks, audit preparation and resolution, team training.
Preferred skills
Medical or biology background, experience with international EDC studies.
Technologies
Medidata Rave, Oracle Inform
Responsibilities
Coordinate data management activities including EDC development, data collection, cleaning, and reconciliation; Develop Data Validation Plans and Edit Check Specifications; Supervise data entry personnel and resolve data discrepancies; Perform manual CRF reviews and coordinate database locks; Liaise with Document Centers for TMF/eTMF maintenance; Prepare for and attend internal and client audits; Train Assistant Data Managers and clinical teams on CRF completion.
Seniority
Senior, hands-on IC with leadership responsibilities
