Senior Clinical Trial Associate

Dyne Therapeutics; Waltham (MA); On-site; USD 86,000 - 105,000; Full time

Job summary

Dyne Therapeutics is seeking a Senior Clinical Trial Associate to support global clinical trials. Based in Waltham, MA, you will help plan, execute, and closeout trials, coordinating with CROs, vendors, and investigative sites to ensure quality and compliance.

You will manage study documents, tracking tools, and TMF activities, while contributing to process improvements across the Clinical Operations team. A strong attention to detail and clear communication are essential.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field preferred.
• 3+ years of hands-on clinical operations or drug development experience.
• Working knowledge of ICH-GCP guidelines, regulatory requirements, TMF expectations, and inspection readiness principles.
• Experience collaborating across multiple functional areas such as Clinical Operations, Regulatory Affairs, Data Management, and vendors.
• Proficiency with clinical trial tracking systems, document management tools, Microsoft Office, and other systems used to support clinical trial execution.

Responsibilities

• Support the Clinical Study Lead and cross-functional study team across all phases of global clinical trial execution.
• Partner with the Clinical Study Lead to facilitate communication across internal study teams, CROs, vendors, and external partners.
• Track study metrics, milestones, site activation progress, enrollment trends, and vendor deliverables.
• Support review, coordination, and quality control of essential study documents and regulatory materials.
• Assist with development and maintenance of Sponsor study documents and materials.
• Attend meetings and maintain agendas, minutes, and action trackers.
• Coordinate logistics for investigator meetings and site communications.
• Collect, file, and track TMF documents and support inspection readiness.

Skills

Clinical operations

ICH-GCP knowledge

Regulatory requirements

Cross-functional collaboration

Independent work

Communication

Education

Bachelor’s degree in life sciences/healthcare

Tools

Microsoft Office

TMF tracking systems

Document management tools

Job description

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) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

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 Dyne’s 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 Responsibilities

• 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, escalated issues appropriately, and follow through on commitments with urgency and attention to quality

Education and Skills Requirements

• Bachelor’s 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 Dyne’s values and commitment to patients
• Willingness to travel for job‑related activities, including investigator meetings, site visits, conferences, or vendor meetings, if required (expected travel for this position is ~5%)

#LI-Onsite

MA Pay Range

$86,000 - $105,000 USD

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.