Senior Clinical Trial Associate
Dyne Therapeutics
August 13, 2026
On-site
Waltham, MA
Clinical Research and Development
Primary Responsibilities:
- Support the Clinical Study Lead and cross-functional study team across all phases of global clinical trial execution (feasibility, planning, start-up, enrollment, maintenance, closeout)
- Partner to facilitate communication across internal teams, CROs, vendors, and external partners; proactively identify risks, resolve issues, and keep activities on track
- Track study metrics and operational milestones (site activation, enrollment trends, vendor deliverables, Sponsor oversight); ensure tracking tools are accurate and current
- Support review/coordination/quality control of essential study documents (ICFs, site initiation visit materials, regulatory documents, study plans, recruitment materials, manuals, trackers) for consistency, accuracy, and compliance
- Assist with development/routing/distribution/maintenance of Sponsor study and operational materials (protocols, amendments, admin letters, pharmacy manuals, study reference materials)
- Attend study meetings; prepare agendas, materials, minutes, decision logs, and action item trackers
- Coordinate logistics/materials for investigator meetings, PI calls, site communications, conferences, and vendor meetings
- Collect, file, reconcile, and track Trial Master File (TMF) documents; conduct routine TMF reviews and support inspection readiness
- Improve Clinical Operations processes (standardization, efficiency, quality, continuous improvement)
- Maintain/update tracking tools, dashboards, contact lists, logs, training records, and other resources
- Communicate professionally; build relationships; escalate issues appropriately; follow through with urgency and quality
Education/Qualifications:
- Bachelor’s degree in life sciences/healthcare or related field preferred (equivalent education/experience considered)
- 3+ years in clinical operations or drug development (preferably Sponsor; global/multi-site exposure)
- Working knowledge of clinical trial operations, ICH-GCP, regulatory requirements, TMF expectations, inspection readiness
- Cross-functional collaboration experience (e.g., Clinical Ops/Dev, Regulatory, QA, Data Mgmt, Biostatistics, Medical Writing, Clinical Supply, Finance, vendors)
- Proficiency with clinical tracking systems, document management tools, Microsoft Office, and related systems
- Ability to work independently, manage competing priorities, and deliver accurate high-quality work
- Professionalism, discretion, integrity, accountability, alignment with patient focus
Skills/Other:
- Willingness to travel (~5%) for job-related activities
Location:
- Waltham, MA
- Support the Clinical Study Lead and cross-functional study team across all phases of global clinical trial execution (feasibility, planning, start-up, enrollment, maintenance, closeout)
- Partner to facilitate communication across internal teams, CROs, vendors, and external partners; proactively identify risks, resolve issues, and keep activities on track
- Track study metrics and operational milestones (site activation, enrollment trends, vendor deliverables, Sponsor oversight); ensure tracking tools are accurate and current
- Support review/coordination/quality control of essential study documents (ICFs, site initiation visit materials, regulatory documents, study plans, recruitment materials, manuals, trackers) for consistency, accuracy, and compliance
- Assist with development/routing/distribution/maintenance of Sponsor study and operational materials (protocols, amendments, admin letters, pharmacy manuals, study reference materials)
- Attend study meetings; prepare agendas, materials, minutes, decision logs, and action item trackers
- Coordinate logistics/materials for investigator meetings, PI calls, site communications, conferences, and vendor meetings
- Collect, file, reconcile, and track Trial Master File (TMF) documents; conduct routine TMF reviews and support inspection readiness
- Improve Clinical Operations processes (standardization, efficiency, quality, continuous improvement)
- Maintain/update tracking tools, dashboards, contact lists, logs, training records, and other resources
- Communicate professionally; build relationships; escalate issues appropriately; follow through with urgency and quality
Education/Qualifications:
- Bachelor’s degree in life sciences/healthcare or related field preferred (equivalent education/experience considered)
- 3+ years in clinical operations or drug development (preferably Sponsor; global/multi-site exposure)
- Working knowledge of clinical trial operations, ICH-GCP, regulatory requirements, TMF expectations, inspection readiness
- Cross-functional collaboration experience (e.g., Clinical Ops/Dev, Regulatory, QA, Data Mgmt, Biostatistics, Medical Writing, Clinical Supply, Finance, vendors)
- Proficiency with clinical tracking systems, document management tools, Microsoft Office, and related systems
- Ability to work independently, manage competing priorities, and deliver accurate high-quality work
- Professionalism, discretion, integrity, accountability, alignment with patient focus
Skills/Other:
- Willingness to travel (~5%) for job-related activities
Location:
- Waltham, MA