Clinical Data Manager II
Core
Manages clinical trial data from study start-up to post database lock, overseeing database development, testing, and quality control for assigned projects.
Role type
Senior Clinical Data Manager
Builds
Clinical databases and data management documentation
Domain
Clinical research / Drug development
Required skills
Clinical Data Management, CRF specification, Database build and testing, Data query resolution, Medical coding (MedDRA/WHODrug), CDISC standards, Vendor liaison, SAS programming basics, SOP development
Preferred skills
Oncology therapeutic experience, Dictionary medical coding, CDISC standards (CDASH, SDTM, ADaM)
Responsibilities
Lead Primary Data Management (DM) contact for assigned projects, Develop CRF specifications from protocols, Conduct database build UAT and maintain documentation, Review and resolve clinical trial data queries, Coordinate SAE/AE reconciliation, Liaise with third-party vendors, Train clinical research personnel on EDC and study specifics, Perform line listing data review and metric reporting.
Seniority
Senior, hands-on IC