Director, Data Management
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Role details
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Job description
Maze Therapeutics is seeking a Director of Data Management to lead clinical data management strategy and execution across multiple development programs. Reporting to the Vice President of Biometrics, you will partner with Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, and external vendors to ensure the delivery of high-quality, compliant, and analysis-ready clinical data.
This role combines strategic leadership with operational oversight and will play a critical part in supporting clinical development, regulatory submissions, and key business decisions., * Lead clinical data management activities across multiple studies and development phases.
- Develop and implement data management strategies, standards, and best practices.
- Serve as the subject matter expert for data management processes, systems, and regulatory requirements.
- Oversee key deliverables, including DMPs, CRFs/eCRFs, edit checks, data review, reconciliation activities, and database locks.
- Ensure timely, accurate, and consistent clinical data collection and cleaning.
- Review and approve study documentation and ensure readiness for analysis and reporting.
- Partner with Biostatistics, Medical Writing, and Clinical Operations to support study execution and reporting.
- Manage CROs and external vendors to ensure quality, timelines, and deliverables are met.
- Support the evaluation and optimization of EDC systems and related technologies.
- Provide strategic input into protocol design, operational planning, and risk mitigation.
- Mentor and develop data management team members while promoting collaboration and knowledge sharing.
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
- 8+ years of clinical data management experience within biotech, pharmaceutical, or CRO settings.
- 3+ years of leadership experience managing people, projects, or both.
- Experience with EDC platforms such as Medidata Rave or Oracle InForm.
- Strong knowledge of clinical trial operations, data management processes, and regulatory requirements.
- Proven ability to work cross-functionally, influence stakeholders, and lead through collaboration.
- Strong mentoring, communication, and organizational skills.
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