Trial Master File Sr. Manager, Clinical Operations

The Position 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 gaps, and sustained compliance with GCP and regulatory requirements. As Maze transitions TMF management in-house, you will lead implementation of the electronic TMF platform, establish sponsor-level standards and workflows, and build the operational infrastructure needed to support current and future studies. This role is ideal for an experienced TMF professional who thrives in a fast-paced biotech environment, enjoys building processes from the ground up, and is passionate about developing high-quality, inspection-ready Trial Master Files. This position will report into the Head of Clinical Operations. The Impact You’ll Have TMF Strategy & Operational Leadership Lead the strategic transition of TMF management from an outsourced model to an internally managed capability. Partner with Clinical Operations and Information Technology to evaluate, implement, configure, and optimize the organization's electronic TMF (eTMF) platform. Develop and maintain TMF governance, business processes, filing standards, taxonomy, indexing structures, and document management workflows. Co-author and maintain sponsor-level TMF Standard Operating Procedures (SOPs), work instructions, guidance documents, and training materials. Identify opportunities to improve TMF processes, technology, and operational efficiency while promoting organizational best practices. Evaluate, implement, and leverage AI-enabled solutions to improve TMF quality, automate document workflows, enhance inspection readiness, and drive operational efficiency. TMF Management & Program Support Serve as the primary TMF subject matter expert supporting multiple early phase, Phase 2, and Phase 3 clinical programs. Partner with Clinical Operations Study Leads and study teams to develop study-specific TMF management plans and document oversight strategies. Provide guidance to study teams, functional contributors, CROs, and vendors on TMF expectations, document ownership, filing timelines, and quality standards. Ensure TMF documents are filed accurately, completely, and within established timelines throughout the lifecycle of each clinical study. Monitor TMF health through routine completeness, timeliness, and quality reviews, proactively identifying and resolving document gaps. Inspection Readiness & Quality Management Partner closely with Quality Assurance to lead TMF inspection readiness activities across all clinical programs. Develop and maintain a continuous inspection readiness strategy that ensures Trial Master Files remain complete, accurate, contemporaneous, and inspection-ready at all times. Conduct routine TMF quality reviews and completeness assessments in collaboration with Quality Assurance and study teams. Identify TMF deficiencies, inspection risks, and compliance gaps, driving timely…