Principal Data Manager

Role: Principal Data Manager overseeing clinical trial data management within a biopharma setting focused on rare diseases. Objectives include ensuring high-quality, compliant data collection and management for clinical programs. Responsibilities encompass leading data management activities, supervising CRO/vendor collaborations, system integrations, data review, and process development; managing timelines, budgets, and regulatory readiness; and supporting study design from a data perspective. Qualifications: BS/MS in Life Sciences or related field; extensive experience (typically 8+ years) in clinical data management, especially in drug development for rare diseases; proficiency with EDC systems like Medidata RAVE; strong knowledge of ICH, GCP, CDASH, SDTM, and dictionary coding (MedDRA, WHODrug); proven leadership in CRO oversight and data integration projects; and excellent communication and project management skills. Preferred: AI models for data efficiency, and experience in managing outsourced studies. High-Value: Focus on rare disease therapies, clinical trials (pre-IND to Phase 3), data integrity, regulatory compliance, and cross-functional collaboration across clinical operations, biometrics, and vendors. Work setup involves a hybrid/remote environment in San Diego with approximately 10% travel.