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Senior Clinical Trial Associate

Waltham, MA

Company Overview:

Dyne Therapeutics is focused on 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 Senior Clinical Trial Associate (CTA) provides Clinical Operations support in the initiation, execution and close out of global clinical trials. The Sr. CTA has the responsibility to support the study teams to deliver high-quality results in a cost-effective and timely manner. The Sr. 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 
  • 3+ 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 position is <5%) 

 

 

#LI-Onsite

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.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

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.

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