Senior Clinical Trial Associate
Department: 121 Clinical OperationsLocation: Waltham, MA
Company Overview:
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, 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 with flexible work schedule, but without the possibility of being a remote role. Applicants must be local or able to relocate to the area.
Key Responsibilities of the Role:
- 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, 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
- 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
Education and Experience Requirements:
- Bachelor’s degree
- 2+ years of relevant hands-on drug development experience in CRO or 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, Biostats, Medical Writing, Clinical Supply, Finance
Other Essentials and Key Success Factors:
- Intellectual curiosity, innovation and creative problem solving
- Ability to think critically in fast-paced environment with a keen sense of urgency
- Self-motivated and able to work autonomously, as well as a collaborative member of a team
- Highly organized and detail-oriented with a passion to deliver high-quality results
- Strong verbal and written communication skills with an ability to build relationships both internally and externally
- Highest levels of professionalism, confidence, personal values and ethical standards
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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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