Principal Data Manager

Role: Principal Data Manager overseeing clinical trial data management processes for rare disease therapies, ensuring data quality, integrity, and regulatory compliance. Responsibilities include managing CRO/vendor data activities, system integrations, data review, discrepancy resolution, and developing data management documentation. The role involves cross-functional collaboration, strategic planning for database locks, and contributing to SOP and protocol development. Requirements: Bachelor's degree in Life Sciences, Bioinformatics, or related field; 8+ years in clinical data management within biopharma, with experience in EDC systems (preferably Medidata RAVE), GCP, and ICH guidelines. Skilled in SDTM/CDASH standards, vendor management, data integration, and leveraging AI models for efficiency. Preferred skills include knowledge of MedDRA/WHODrug, project management, and experience managing outsourced studies. High-Value: rare disease therapeutic focus, clinical trial data management, GCP compliance, cross-functional teamwork, and experience in EDC and vendor oversight. Work setup: remote with approximately 10% travel; based in San Diego.