Clinical Trial Associate
Company: Dyne Therapeutics
Location: Waltham
Posted on: July 8, 2025
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Job Description:
Company Overview: 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
myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy
(DMD), and 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. Learn more 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 position is 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.
Keywords: Dyne Therapeutics, Framingham , Clinical Trial Associate, Science, Research & Development , Waltham, Massachusetts