Senior TMF Specialist

Role Summary:

The Senior TMF Specialist supports the ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. 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 effectively with cross-functional teams and external stakeholders at all levels of the organization  

• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment 

• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations 

• Demonstrated ability to influence cross-functional stakeholders without direct authority 

• Highly collaborative team player with a strong cross-functional mindset 

• Meticulous attention to detail with a commitment to quality and compliance 

• Positive, proactive, and resilient team member who embodies Dyne’s Core Values  

• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases 

• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 

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