Senior Manager, Trial Master File Operations
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 Manager, Trial Master File (TMF) Operations, is the TMF business process owner, providing leadership and strategic direction and is responsible for ensuring TMF processes and related documentation are of the highest quality and that they comply with ICH regulations, GCP guidelines and expectations of regulatory authorities.
This role has the flexibility of being remote will ability to periodically travel to Waltham, MA.
Key Responsibilities of the Role:
- Drive the development and implementation of global strategy as it relates to the TMF with respect to processes, systems, vendors, roles and governance to ensure that Dyne is inspection ready at all times. Serve as the primary point-of-contact for all TMF related activities.
- Oversee TMF resources managing the ongoing quality control reviews of study TMFs, utilizing a risk-based approach.
- Develop KPI and performance metrics and establish and lead oversight and governance processes.
- Ensure and oversee implementation of TMF processes in line functions. Develop and deliver training on essential documents and TMF processes/expectations.
- Conduct oversight of the third-party vendors supporting TMF activities to ensure service meets expectations.
- Maintain awareness of evolving standards, technologies and best practices and evolve TMF operating model as needed.
Education and Experience Requirements:
- Bachelor’s Degree or equivalent with significant demonstrable related experience in pharmaceutical / biotech in a GCP-regulated environment
- 5+ years of working in clinical research and drug development with specific experience in clinical documentation and/or information management
- Strong working knowledge of the TMF Reference Model, Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
- Extensive knowledge of regulatory standards (e.g ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management and records management
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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