Associate Director, Clinical Data Management

Position Summary

Associate Director, Clinical Data Management

• Provide clinical data management leadership for complex clinical development projects; align on and drive data collection requirements.
• Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data on time.
• Lead end-to-end clinical data management; primary point of contact for internal/external study teams.
• Set program-level data collection/review standards with cross-functional teams and global standards.
• Oversee third-party vendors for data management deliverables; manage data currency.
• Collaborate on EDC and related data collection systems (eCOA, External Data, Safety Gateway); enforce data standards and quality expectations.
• Author/review DM study plans and documents (e.g., Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines).
• Chair Data Quality Review meetings to ensure data currency, quality, and completeness.
• Represent DM on cross-functional project and submission teams; lead/support Health Authority inspections, audits, and CAPA.
• Coach junior Data Management Leads; lead/co-chair department Data Management Lead forums.

• Bachelor’s degree in life sciences/data science/statistics (advanced degree preferred).
• 7+ years Biopharma/CRO experience; 3+ years in study/program leadership.
• Travel: 5–10%.

• Clinical drug development process knowledge; FDA/ICH and data management best practices.
• EDC systems expertise (Medidata RAVE preferred); strong MS Office skills.
• Strong project management, metrics analysis/reporting; excellent oral/written communication.
• Knowledge of submission requirements (e.g., NDA/BLA/MAA).

• Health coverage; wellbeing support; financial wellbeing/protection (401(k), disability, life/accident, insurance, legal support).
• Paid time off options (flexible time off and/or vacation per employee type) and other eligibility-based leaves.