Head of Clinical Data Management

Clinical Data Management Leader

Provides strategic and operational leadership for clinical data management activities across multiple clinical programs to deliver high-quality, inspection-ready clinical data supporting clinical development, regulatory submissions, and business decision-making. May function as the lead for Clinical Data Management or as a senior leader within the function based on organizational needs.

Accountable for overall Clinical Data Management strategy, operating model, budget and resource planning, vendor ecosystem, and development of leadership capability within the function when serving in a functional leadership capacity. Ensures execution quality across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and vendor oversight. Establishes data quality plans, operational metrics, and risk-based approaches to improve predictability, reduce rework, and ensure timely delivery of reliable clinical data.

Collaborates cross-functionally to enable fit-for-purpose data collection, cross-study consistency, and end-to-end traceability from protocol and CRF design through analysis-ready datasets. Leads continuous improvement and technology enablement initiatives, including scalable EDC build methodologies, standard libraries, automation, AI-enabled data review workflows, and solutions supporting end-to-end biometrics standardization. Manages and develops internal staff and external partners, strengthening leadership capability within the function while ensuring effective resource planning, vendor governance, and succession planning.

Your contributions (include, but are not limited to):

• Direct clinical data management activities across assigned studies, programs, and/or sub-functional areas to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables
• Provide strategic and operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and clinical data delivery
• Lead development and execution of key CDM deliverables, including data management plans, data review plans, database specifications, edit check specifications, query management processes, quality review activities, database audits, and database lock plans
• Provide early strategic input into protocol design, CRF design, data standards, endpoint implementation, and cross-study consistency to enable fit-for-purpose data collection and high-quality analysis-ready data
• Partner with Biostatistics and Statistical Programming to support end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines.
• Establish and monitor CDM metrics, dashboards, and governance mechanisms to track data quality, query trends, vendor performance, cycle times, reconciliation status, lock readiness, and milestone achievement
• Direct identification, escalation, and resolution of complex CDM issues, including data quality trends, database discrepancies, external data reconciliation challenges, vendor performance concerns, and cross-functional process risks.
• Oversee CROs, vendors, contractors, and other external partners supporting CDM activities; monitor performance, deliverables, quality, timelines, issue resolution, and compliance with contractual and regulatory expectations
• Represent CDM in cross-functional governance, study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress to senior leadership
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors to align CDM activities with study timelines, regulatory expectations, program goals, and business needs
• Develop and improve CDM processes, standards, templates, work practices, and governance mechanisms to increase operational efficiency, inspection readiness, quality, and…