Head of Clinical Data Management

Role: Head of Clinical Data Management leading strategy and operations across early to post-marketing development phases for biopharmaceuticals. Responsibilities: oversee data management activities including CRF/eCRF design, database validation, data review, external data integration, medical coding, and regulatory submission readiness; build and lead a high-performing, compliant, inspection-ready team; drive modernization, automation, and innovative data technology initiatives; ensure quality, risk mitigation, and operational excellence in a GxP environment; collaborate with Biometrics, IT, and cross-functional teams to advance integrated data ecosystems. Requirements: Bachelor’s in Life Sciences, Computer Science, or related field; 12+ years in clinical data management within pharma/biotech; 8+ years of leadership managing complex portfolios; deep knowledge of clinical trial data lifecycle, GCP, global regulatory standards, and data systems including EDC; experience with Phase 2 and 3 global trials, regulatory submissions, and vendor oversight. Preferred: Master’s or PhD, experience in rare disease, respiratory, immunology, or gene therapy programs. High-Value: global clinical trial data, modern data technology, automation, regulatory compliance, inspection readiness. WorkSetup: fully remote with occasional domestic/international travel (~10%).