Clinical Trial Associate Position Available In Middlesex, Massachusetts

Job Description:

Company Overview:

Dyne Therapeutics is discovering and advancinginnovative life-transforming therapeutics for people living withgenetically driven neuromuscular diseases. Leveraging themodularity of its FORCE™ platform, Dyne is developing targetedtherapeutics 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) andDuchenne muscular dystrophy (DMD) and preclinical programs forfacioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary:

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

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

Primary Responsibilities Include:

Support theClinical Study Lead and overall study team for all phases of studyconduct (feasibility, planning and start up, conduct/maintenance,and closeout) for global clinical trials Collaborate with theClinical Study Lead to facilitate cross-functional team and Clientcommunications for proactive, study-wide problem solving regardingstudy progress and trial issues during the study Track metricsrelated to Sponsor oversight; work closely with CRO, reviewactivity tracking for accuracy and completeness Provide support inreviewing study documents, e.g., ICFs, SIV slides, essentialregulatory documents, study plans, recruitment materials, etc. toensure quality and consistency Assist the clinical team indevelopment and distribution of Sponsor study documents, e.g.,protocols, administrative letters, and pharmacy manuals Attend bothinternal and external meetings (CRO or vendor), assist withgeneration and maintenance of meeting materials, capture meetingminutes and track action items as required Support the clinicalteam with coordination and preparation for investigator meetings,PI calls, conferences as well as internal meetings Collect andtrack documents for the trial master file (TMF), and perform TMFreviews to ensure completeness and support inspection readinessactivities Take initiative to support the Clinical Operations teamto identify and implement best practices and continuous improvementplans within the department Maintain study tracking tools

Educationand Skills Requirements:

Bachelor’s degree 2 years of relevanthands-on drug development experience in Sponsor setting Knowledgeof clinical trial operations, ICH, GCP Guidelines and otherapplicable regulatory requirements Experience working in a teamacross multiple functional areas, e.g., Quality Assurance, DataManagement, Biostatistics, Medical Writing, Clinical Supply,Finance Willingness to travel for job related activities ifrequired (expected travel for this position is LI-Onsite Thestatements contained herein reflect general details as necessary todescribe the principles functions for this job, the level ofknowledge and skill typically required, and the scope ofresponsibility, but should not be considered an all-inclusivelisting of work requirements. Individuals may perform other dutiesas assigned, including work in other functional areas to coverabsences or relief, to equalize peak work periods or otherwisebalance workload. This description is not intended to beconstructed as an exhaustive list of duties, responsibilities, orrequirements for the position. This position may change or assumeadditional duties at any time. The employee may be requested toperform different or additional duties as assigned. All Employeesare expected to adhere to all company policies and act as a rolemodel for company values. Dyne Therapeutics is an equal opportunityemployer and will not discriminate against any employee orapplicant on the basis of age, color, disability, gender, nationalorigin, race, religion, sexual orientation, veteran status, or anyclassification protected by federal, state, or local law.