Clinical Trial Associate

Company Overview:

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 

Role Summary:

The Clinical Trial Associate (CTA) provides Clinical Operations support in the initiation, execution and close out of global clinical trials. The CTA has the responsibility to support the study teams to deliver high-quality results in a cost-effective and timely manner. The CTA will also support the Clinical Operations team with establishing key practices and procedures.

This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

• Support the Clinical Study Lead and overall study team for all phases of study conduct (feasibility, planning and start up, conduct/maintenance, and closeout) for global clinical trials 
• Collaborate with the Clinical Study Lead to facilitate cross-functional team and Client communications for proactive, study-wide problem solving regarding study progress and trial issues during the study 
• Track metrics related to Sponsor oversight; work closely with CRO, review activity tracking for accuracy and completeness
• Provide support in reviewing study documents, e.g., ICFs, SIV slides, essential regulatory documents, study plans, recruitment materials, etc. to ensure quality and consistency 
• Assist the clinical team in development and distribution of Sponsor study documents, e.g., protocols, administrative letters, and pharmacy manuals 
• Attend both internal and external meetings (CRO or vendor), assist with generation and maintenance of meeting materials, capture meeting minutes and track action items as required
• Support the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal meetings
• Collect and track documents for the trial master file (TMF), and perform TMF reviews to ensure completeness and support inspection readiness activities
• Take initiative to support the Clinical Operations team to identify and implement best practices and continuous improvement plans within the department 
• Maintain study tracking tools 

 

Education and Skills Requirements:

• Bachelor’s degree 
• 2+ years of relevant hands-on drug development experience in Sponsor setting 
• Knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
• Experience working in a team across multiple functional areas, e.g., Quality Assurance, Data Management, Biostatistics, Medical Writing, Clinical Supply, Finance 
• Willingness to travel for job related activities if required (expected travel for this pos