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 Include: 

• 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: 

• 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%) 

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