Lead Clinical Data Manager responsible for directing data management activities across the full lifecycle of one or more clinical studies, from database setup through lock and close-out. The role includes managing CRO and EDC vendor performance, authoring core data management documentation (DMP, DRP, guidelines), ensuring compliance with FDA regulations, ICH-GCP, and CDISC standards (CDASH, SDTM), and representing Data Management on cross-functional teams.… Requires 7–10+ years of clinical data management experience with demonstrated expertise in EDC systems (Medidata Rave preferred), vendor oversight, FDA/ICH/HIPAA regulations, and oncology knowledge including RECIST/RANO criteria.
San DiegoLast seen 7 days ago