Senior Clinical Data Manager
Core
Lead Clinical Data Manager responsible for end-to-end data management from study startup to database lock, overseeing database development, quality control, and team leadership.
Role type
Senior Clinical Data Manager (Lead DM)
Builds
Clinical databases and data management documentation
Domain
Clinical trials, drug/device/biologic development
Required skills
Clinical data management, database development, quality control, medical coding (MedDRA/WHODrug), CDISC standards, vendor management, SAS programming, project management
Preferred skills
Clinical/scientific/healthcare discipline experience, Oncology/Orphan Drug therapeutic experience
Technologies
EDC systems, Microsoft Office, SAS
Responsibilities
Oversee project data entry process and quality control, develop CRF specifications and edit check requirements, conduct database build UAT, manage data management documentation, train clinical research personnel, review and query clinical trial data, coordinate SAE/AE reconciliation, liaise with third-party vendors, assist with SAS programming, troubleshoot operational problems, participate in strategy meetings and bid defenses.
Seniority
Senior, hands-on IC with leadership responsibilities