Director, Data Management

Trova Talent•San Diego, CA

About The Position

The Director, Data Management will lead clinical data management for the company and own data management strategy, standards, and delivery to ensure high-quality, submission-ready clinical data. The role manages clinical data management staff and/or vendors, with supervisory scope scaling with the program. The position works cross-functionally with Biostatistics, Statistical Programming, and Clinical Operations and is suited to a leader with strong data management and CDISC/regulatory expertise.

Requirements

  • Bachelor's degree in a life-science, data, or related discipline required.
  • 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.
  • Strong organization, leadership, and cross-functional collaboration.

Nice To Haves

  • Advanced degree.
  • Rare disease or advanced-therapy experience.

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.
  • Manage clinical data management staff and/or vendors, with supervisory scope scaling with the program.
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