Lead Clinical Data Manager

Summary

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.