Senior Clinical Trial Associate

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) Pompe disease and multiple DMD mutations. At Dyne we are on a mission to deliver functional improvement for individuals families and communities. Learn more at and follow us onXLinkedInandFacebook.

Role Summary:

The Senior Clinical Trial Associate (CTA) is a key member of the Clinical Operations team responsible for supporting the successful planning execution oversight and closeout of Dynes global clinical trials. This role partners closely with Clinical Study Leads cross-functional study team members CROs vendors and investigative sites to help ensure trials are delivered with quality efficiency compliance and a strong focus on patients. The Senior CTA contributes to day-to-day study operations maintains critical study documentation and tracking tools supports inspection readiness and helps establish scalable processes and best practices as Dyne continues to advance its clinical development portfolio. Success in this role requires strong organization attention to detail proactive communication sound judgment accountability and the ability to manage competing priorities in a dynamic clinical development environment.

This role is based in Waltham MA.

Primary ResponsibilitiesInclude:

• Support the Clinical Study Lead and cross-functional study team across all phases of global clinical trial execution including feasibility study planning start-up enrollment maintenance and closeout activities
• Partner with the Clinical Study Lead to facilitate effective communication across internal study teams CROs vendors and other external partners helping to proactively identify risks resolve issues and keep study activities on track
• Track study metrics operational milestones site activation progress enrollment trends vendor deliverables and Sponsor oversight activities; work closely with CROs and vendors to ensure tracking tools are accurate complete and current
• Support the review coordination and quality control of essential study documents including informed consent forms site initiation visit materials essential regulatory documents study plans recruitment materials manuals trackers and other trial-related documents to ensure consistency accuracy and compliance
• Assist with the development routing distribution and maintenance of Sponsor study documents and operational materials such as protocols protocol amendments administrative letters pharmacy manuals study reference materials and team communications
• Attend internal study team meetings and external CRO/vendor meetings; prepare and maintain agendas meeting materials minutes decision logs and action item trackers to support accountability and timely follow-through
• Coordinate logistics and materials for investigator meetings principal investigator calls site-facing communications conferences vendor meetings and other study-related forums
• Collect file reconcile and track essential documents for the trial master file (TMF); conduct routine TMF reviews identify gaps follow up on missing documentation and support ongoing inspection readiness activities
• Take initiative to improve Clinical Operations processes by identifying opportunities for standardization efficiency quality and continuous improvement within study teams and across the department
• Maintain and update study tracking tools dashboards contact lists document logs training records and other operational resources to support transparency and timely decision-making
• Use sound judgment intellectual curiosity and a continuous improvement mindset to identify practical solutions improve ways of working and support consistent execution across study teams
• Communicate clearly and professionally with internal and external stakeholders build effective working relationships escalate issues appropriately and follow through on commitments with urgency and attention to quality

Education and Skills Requirements:

• Bachelors degree in life sciences healthcare or a related field preferred; equivalent combination of education and relevant experience may be considered
• 3 years of relevant hands-on clinical operations or drug development experience preferably in a Sponsor setting and with exposure to global or multi-site clinical trials
• Working knowledge of clinical trial operations ICH-GCP guidelines regulatory requirements TMF expectations and inspection readiness principles
• Experience collaborating across multiple functional areas such as Clinical Operations Clinical Development Regulatory Affairs Quality Assurance Data Management Biostatistics Medical Writing Clinical Supply Finance and external vendors
• Proficiency with clinical trial tracking systems document management tools Microsoft Office applications and other systems used to support clinical trial execution and documentation
• Demonstrated ability to work independently collaborate effectively within cross-functional teams manage competing priorities and deliver accurate high-quality work with strong follow-through
• High level of professionalism discretion integrity accountability and alignment with Dynes values and commitment to patients
• Willingness to travel for job-related activities including investigator meetings site visits conferences or vendor meetings if (expected travel for this position is 5%)

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The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education experience job-related knowledge and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job the level of knowledge and skill typically required and the scope of responsibility but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned including work in other functional areas to cover absences or relief to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age color disability gender national origin race religion sexual orientation veteran status or any classification protected by federal state or local law.