Role Summary:
The Senior Manager, TMF and Inspection Readiness will play a key role in the clinical operations department and is responsible for the day-to-day management of TMF files across all clinical trials at Dyne, including the upload, review, and approval of TMF documents.
The Senior Manager will co-author and manage TMF documents such as TMF Plan, Index, SOPs, and other guidance documents. The Senior Manager will also ensure quality management of studies by reporting TMF metrics periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues e.g. CAPAs. This role will work closely with Clinical Operations in high-level projects, developing processes, and strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of external vendors ensuring that study documents are managed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.
The Senior Manager will also lead inspection readiness activities for Dyne clinical operations including management of clinical operations storyboards, coordination of inspection readiness activities and action items from preparatory meetings.
This role is based in Waltham, MA without the possibility of being remote.
Primary Responsibilities Include:
- Management of clinical studies to ensure timely, consistent, and quality setup and maintenance of TMF requirements and processes. This includes document QC, upload, remediation, and query management
- Ensure that Dyne staff is appropriately trained in systems, processes, and SOPs
- Develop successful working relationships with TMF stakeholders, both internal and external
- Responsible for risk mitigation, action plans, and issue resolution along with proactively communicating changes, updates, and issues to all TMF stakeholders
- Monitor and identify TMF trends and escalate concerns to management
- Oversight of internal and external TMF audits and inspection activities which includes oversight of the development and timely resolution of corrective action plans related to TMF findings
- Develop lessons learned and share across programs and foster a culture of constant improvement as a TMF ambassador
- Participate in the identification and selection of an in-house eTMF vendor system; lead implementation of the system cross-functionally
- Review data quality outputs and audit outputs to identify trends; develop process improvements, includes reviewing and reporting metrics established for performance TMF reviews and providing action plans as appropriate
- Lead clinical operations storyboard activities as key operations SME on inspection readiness preparation
- Track and follow up on action items following inspection activities from identification to action resolution
- Participate in internal process improvement projects/initiatives to continuously improve operational excellence in support of inspection readiness
- Manage action items from inspection readiness preparation meetings and coordinate document collection with internal and external stakeholders
- Attend study team and other meetings as needed
Education and Skills Requirements:
- Undergraduate degree in a scientific or health related discipline.
- 7+ years of overall relevant clinical operations and TMF experience at a biotechnology, pharmaceutical, or TMF vendor
- 4+ years of experience working in eTMF system software; experience in Veeva Vault eTMF system software is highly preferred.
- Understanding of the clinical trial lifecycle
- Experience in handling clinical trial-related documents required
- Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents
- Experience with global agency inspections
- Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
- Strong communication skills – verbal and written
- Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality)
- Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with SharePoint
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
