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Director, Data Management
- Hiring from
- Probably Worldwide
- Work type
- Remote
- Posted
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Our client is currently seeking a Director, Data Management to join their team!
Position Summary
As the Director, Data Management you will lead clinical data management for the company. You will own data management strategy, standards, and delivery to ensure high-quality, submission-ready clinical data. The ideal candidate brings strong data management leadership and CDISC/regulatory expertise.
Key Responsibilities
Position Summary
As the Director, Data Management you will lead clinical data management for the company. You will own data management strategy, standards, and delivery to ensure high-quality, submission-ready clinical data. The ideal candidate brings strong data management leadership and CDISC/regulatory expertise.
Key Responsibilities
- Lead data management strategy, planning, and delivery across studies.
- Oversee EDC build, edit checks, data review, query management, and database lock.
- Ensure adherence to CDISC standards, 21 CFR Part 11, and data integrity (ALCOA+).
- Manage data management vendors/CROs and timelines.
- Establish data standards, conventions, and quality processes.
- Partner with Biostatistics, Statistical Programming, and Clinical Operations on data deliverables.
- Build and develop data management capability as programs scale.
- Bachelor's degree in a life-science, data, or related discipline required; advanced degree a plus.
- 10+ years of clinical data management experience, including leadership.
- Strong expertise in EDC systems, CDISC, 21 CFR Part 11, and database lock.
- CRO/vendor oversight and data quality experience.
- Rare disease or advanced-therapy experience preferred.
- Strong organization, leadership, and cross-functional collaboration.
- Manages clinical data management staff and/or vendors; supervisory scope scales with the program.