This position will provide the leadership, subject matter expertise and clinical study team support required to ensure that the electronic Trial Master File (eTMF) is managed in accordance with relevant ICH guidelines, GCP regulatory requirements and other regulations, as appropriate. This role will collaborate cross-functionally to set eTMF practice and standards at Sage, including developing SOPs, work instructions, and operating templates. Additionally, the Director, TMF will oversee and manage internal and external resources engaged in hands on management of the eTMF strategy and contents. This position is responsible for active leadership of eTMF system enhancements and maintenance and partnering with our vendors to map out an eTMF strategy for Sage.
Roles and Responsibilities
- Establish the strategy, management and integration of an electronic TMF system, including vendors and technology. This will involve project management and hands-on participation in the configuration and maintenance of the eTMF.
- Serve as a business owner of the eTMF.
- Build out the eTMF function within Clinical Operations; manage internal and external resources and vendors.
- Accountable for leading key stakeholder discussion, buy-in, and endorsement.
- Create and drive initiatives, timelines, budgets, and resourcing plans.
- Provide adequate training to study teams, including external partners and CRO staff, to ensure that TMF documents are processed in a timely manner and per SOP.
- Create and maintain the eTMF Operating Model to include standards and best practices aligned across multiple programs and organizational goals.
- Actively engage Clinical leaders, QA, and external resources to ensure the receipt, processing and tracking of all clinical project-related documentation, including global study and site documents, in alignment with study TMF management plans.
- Lead meetings to escalate trends, issues, and establish standards, while problem solving and seeking appropriate endorsement across study teams and functions. Communicate ideas, solutions, and standards.
- As the Subject Matter Expert, provide guidance on local and international GCPs related to the eTMF.
- Plan and conduct periodic reviews of the study eTMF per plans. Develop metrics to assess the completeness and quality of the eTMF and effectively communicate status updates to the study team and department management. Work with study team to address gaps, issues and mitigate risks.
- Lead inspection/audit preparation activities and develop CAPA plans, as necessary, for related findings in conjunction with cross-functional leaders.
- Oversee archive preparation of the submission-ready eTMF, liaising with CRO partners to ensure compliance with SOPs and project timelines.
- Experience managing direct reports.
- Identify opportunities for continuous process improvement.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Extensive knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content. Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
- B.S. in a discipline relevant to the biological sciences.
- A minimum of 10 years of experience developing and managing electronic TMFs within the biotech/pharmaceutical industry is essential.
- Previous experience building and leading teams, managing direct reports
- Familiarity with the Trial Master File Reference model and a demonstrated understanding of records management best practices.
- Extensive knowledge of clinical documents that are maintained in the eTMF.
- A candidate with prior NDA inspection readiness experience is highly desired.
- Flexibility to adapt to the dynamic needs of a growing biotech company.
- Fluid use of MS Project, Excel, PowerPoint, and Outlook.
- Demonstrated experience working in a matrix environment.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of SAGE.