Senior TMF Specialist

Dyne Therapeutics•Waltham, MA

3d•Onsite

About The Position

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.

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

Responsibilities

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 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