ich-gcp jobs in San Diego

Director-level role leading clinical data management across multiple development programs at a therapeutic company. Responsible for overseeing data management CROs and vendors, ensuring data quality and regulatory compliance, managing the clinical data lifecycle (database build, data review, reconciliation, lock), and leading cross-functional teams.…See more Requires 10+ years of clinical data management experience, deep knowledge of FDA/EMA/ICH-GCP requirements, CDISC standards, EDC systems, and demonstrated ability to manage complex global trials.

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.…See more 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.