Director, Data Management and Systems
About the role
Role Summary
The Director of Data Management and Systems (DM) is a strategic and operational leader with deep expertise in DM systems and data standards, responsible for scaling processes and ensuring high-quality, regulatory-compliant data delivery across a fast-paced clinical development environment. This role combines hands-on systems knowledge, vendor oversight experience, and the ability to lead cross-functional study teams ensuring high-quality, regulatory-compliant data delivery that supports timely decision-making and submissions.
The Director is also responsible for overseeing end-to-end data management activities across one or more clinical development programs, bringing program-level leadership and operational discipline to ensure consistency, quality, and regulatory compliance across studies.
The ideal candidate brings a balance of hands-on systems knowledge, vendor oversight experience, and program-level leadership, with a proven ability to scale processes in a fast-paced clinical development environment.
Key Responsibilities
- Systems & Technology Leadership
- Provide strategic and operational leadership for DM systems (e.g., EDC, ePRO/eCOA, RTSM, CTMS integrations).
- Lead selection, implementation, optimization, and governance of DM technologies and platforms to support scalable, high-quality data management across clinical development programs.
- Champion data standards (e.g., CDISC, SDTM) and metadata-driven approaches.
- Partner with Biostatistics, Programming, and IT to ensure seamless data flow and interoperability across systems.
- Evaluate emerging technologies (AI/ML, automation, decentralized trial tools) to enhance data quality and efficiency.
- Program & Study Leadership
- Provide strategic leadership and oversight of DM activities across assigned clinical programs (Phases I–III and beyond).
- Serve as the DM lead on cross-functional program teams, influencing study design, timelines, and data strategy.
- Ensure delivery of high-quality, submission-ready datasets in alignment with