Backed by a16z and GV.
About the role
At Maze Therapeutics, we believe precision medicine has the power to transform the lives of patients with both common and rare diseases. As Trial Master File (TMF) Senior Manager for Clinical Operations, you will serve as the operational leader responsible for the strategy, governance, quality, and execution of the Trial Master File across Maze's clinical development portfolio.
What they're looking for
- Bachelor's degree in Life Sciences, Healthcare Administration, or another scientific or healthcare-related discipline
- 6–8+ years of experience in Clinical Operations, Clinical Trial Management, or Trial Master File management within biotechnology, pharmaceutical, or CRO organizations
- 4–5+ years of dedicated experience managing electronic Trial Master Files (eTMFs) across multiple global clinical studies
- Experience leveraging AI-enabled solutions to improve TMF processes, document quality, reconciliation, inspection readiness, or operational efficiency is preferred
- Demonstrated experience supporting early phase, Phase 2, and Phase 3 clinical trials in a GCP-regulated environment
- Proven experience leading TMF inspection readiness activities and partnering with Quality Assurance to support audits and regulatory inspections
More about this role
At Maze Therapeutics, we believe precision medicine has the power to transform the lives of patients with both common and rare diseases. As Trial Master File (TMF) Senior Manager for Clinical Operations, you will serve as the operational leader responsible for the strategy, governance, quality, and execution of the Trial Master File across Maze's clinical development portfolio. You will play a pivotal role in partnering with cross-functional study teams to maintain complete, accurate, and inspection-ready Trial Master Files for ongoing clinical studies. You will also collaborate with Quality Assurance (QA) on the development and implementation of Maze's in-house TMF strategy and operating model for future clinical programs.
Working closely with Clinical Operations, Quality Assurance, Clinical Science, Regulatory Affairs, Biometrics and study teams, you will help establish scalable TMF processes, systems, and governance that support the organization's continued growth. You will partner closely with the Head of Clinical Operations and Quality Assurance to drive inspection readiness across the clinical portfolio, ensuring routine TMF quality reviews, timely resolution of document...
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