Director & Program Lead – Clinical Data Management

About the role

The Director, Program Lead, Clinical Data Management is responsible for shaping and executing data management strategy across multiple therapeutic programs on a global scale. As the subject‑matter expert, you will ensure consistency, quality, and regulatory compliance while driving continuous improvement.

Key responsibilities

• Define and own program‑ and portfolio‑level data management strategies for all data modalities (eCRF, labs, biomarkers, PRO/eCOA, imaging, etc.).
• Lead risk‑based planning, timelines, and inter‑study dependencies to ensure consistent data collection, integration, validation, UAT, database lock, and inspection readiness.
• Govern cross‑program data standards, specifications, and change control as the Clinical Data Management SME.
• Drive quality, risk management, RCA/CAPA, audits, inspections, and maintain complete, traceable documentation.
• Lead strategic initiatives in data standards, automation, digital enablement, and quality frameworks to improve scalability.
• Represent Global Data Management in program forums and partner with Clinical, Biostatistics, Data Science, IT, and operational leaders.
• Act as escalation point for complex cross‑functional issues, providing senior‑level decision support.
• Support acquisitions and partnerships through data management due diligence and integration oversight.
• Build organizational capability through mentoring, training, and communities of practice.
• Develop and use program‑level dashboards, KPIs, and analytics to guide execution.

Required profile

• Extensive experience in clinical data management within pharmaceutical or biotech environments.
• Proven leadership of multi‑program, global data management teams.
• Deep knowledge of regulatory requirements and data quality standards.
• Strong risk‑management and problem‑solving abilities.
• Excellent stakeholder management and communication skills.

Required skills