medidata-rave jobs in San Diego

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.

Principal Specialist overseeing clinical data management for pharmaceutical studies, responsible for database lock coordination, CRO performance monitoring, and ensuring quality control and audit procedures meet departmental standards. The role requires running data review listings, coding medical history and adverse event data using MedDRA, coding concomitant medications using WHO Drug dictionaries, and collaborating with database programmers to ensure CDISC/SDTM compliance.…See more Requires 8+ years of pharma industry experience (or equivalent with advanced degree), strong knowledge of Good Clinical Data Management Practices, and demonstrated ability to lead and manage teams across multiple projects.

Sr. Principal Specialist will oversee clinical database programming operations, including review/cleaning programs, validation procedures, database migrations, SAS dataset creation, and vendor management within a pharmaceutical environment.…See more The role requires hands-on technical expertise in Medidata Rave, SAS, and SQL alongside strategic leadership of cross-functional teams and oversight of regulatory compliance, inspection readiness, and system implementations. Responsibilities include proactive risk mitigation, evaluation and adoption of new technologies, and acting as a technical liaison across Clinical Data Management, Clinical Operations, Regulatory, and IT. The ideal candidate combines 8+ years of clinical database programming experience (or equivalent with advanced degree) with expert knowledge of CDISC standards, GCP regulations, and end-to-end drug development processes.

Lead clinical data management strategy, governance, and operations across a portfolio of clinical development programs in a biopharmaceutical environment. Manage CDM leaders and professionals, oversee data integrity initiatives, regulatory compliance, and vendor relationships while driving process improvements and technology modernization.…See more Requires 10–14+ years of clinical data management experience in pharma/biotech/CRO settings, with deep expertise in EDC platforms (Medidata Rave preferred), clinical data standards (CDASH, SDTM), GCP, ICH guidelines, and proven senior leadership capability.