Senior Manager, Trial Master File Operations

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 with 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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