Position Summary
Associate Director, Clinical Data Management
Key Responsibilities
- 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.
Qualifications & Experience
- Bachelorβs degree in life sciences/data science/statistics (advanced degree preferred).
- 7+ years Biopharma/CRO experience; 3+ years in study/program leadership.
- Travel: 5β10%.
Required/Preferred Skills
- 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).
Benefits (as listed)
- 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.
Application Instructions
- Apply even if you donβt perfectly match your resume.