Senior TMF Specialist

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Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook . Role Summary: The Sen i or TMF Specialist suppo rts th e ongoing mainte nance, qual it y, and inspect ion read iness of the Trial Master File (TMF) across assigned cl inical stud ies. This role is responsible for the integrity, completeness and compliance of our TMF including accurate filing, tracking, and quality control of TMF documents in accordance with ICH-GCP, the TMF Reference Model, and company procedures. This role requires a deep understanding of regulatory requirements and industry best practices related to TMF management in order to support our clinical trials effectively. This role partners closely with Clinical Operations, Quality, Regulatory and external partners to ensure timely document collection and a complete, inspection-ready TMF. This role is based in Waltham, MA. Primary Responsibilities Include : TMF Operations & Maintenance Participate in the creation, maintenance, and management of the TMF for clinical studies, ensuring compliance and regulatory standards (e.g., ICH, FDA) and internal policies Develop and implement TMF-related processes and procedures to ensure timely and accurate documentation of all trial-related activities Support day-to-day TMF activities for assigned studies, including filing, indexing, and quality control of documents within the eTMF system Ensure accurate , complete, and timely filing of TMF documentation in accordance with applicable SOPs, TMF Reference Model, and regulatory requirements Perform routine TMF completeness and quality checks, identifying missing, incorrect, or misfiled documents Track document deliverables and follow up with study teams, CROs, and vendors to resolve gaps TMF Quality & Inspection Readiness Support ongoing TMF health assessments and inspection readiness activities Assist with TMF-related audit and inspection preparation, including document reconciliation and retrieval , to assess completeness and quality, identifying any gaps and implementing corrective actions as necessary Document TMF issues, deviations, or quality observations and support corrective actions as needed Participate in TMF inspections and audits by regulatory authorities and serve as a contact for TMF-related queries Process Adherence & Continuous Improvement Adhere to company TMF processes, SOPs, and work instructions Identify opportunities for process improvement, standardization, or increased efficiency and escalate recommendations as appropriate Support TMF process updates, system enhancements, and user acceptance testing as needed Training & Documentation Support Support onboarding and training of internal team members and vendors on TMF processes , eTMF system usage , and best practices Maintain TMF-related trackers, logs, and study documentation as required Stay current with industry trends and regulatory changes impacting TMF management Vendor & Technology Management: Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices Cross Functional Partnership & Support: Collaborate with Clinical Operations, Quality, Regulatory, and external partners to support TMF expectations and timelines Serve as a TMF point of contact for assigned studies, answering procedural and process-related questions Education and Skills Requirements: Bachelor's degree in life sciences or a related field 6+ years of experience in clinical operations, TMF management, document management, or a regulated GxP environment Strong knowledge of regulatory requirements and guidelines governing TMF maintenance and management, ICH-GCP, TMF Reference Model, and clinical trial documentation requirements Proven hands-on experience with eTMF systems, document management software, and document quality control Excellent organizational skills and ability to work independently as well as collaboratively in a fast-paced environment Experience working with eTMF systems and CRO/vendor oversight Excellent communication (written and verbal), influencing, and stakeholder management skills Ability to interact effecti

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