General Scope and Summary
The TMF Manager will provide the leadership, subject matter expertise, vendor oversight 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 involves the development of any Standard Operating Procedures (SOPs), work instructions and QC practices relevant to the management of the eTMF, as well as oversight for, and hands-on management of, the eTMF contents.
Roles and Responsibilities
- Oversee the strategy, management and integration of an electronic TMF system, including vendors and technology. This will involve hands-on participation in the configuration and maintenance of the eTMF.
- Serve as a business administrator of the eTMF.
- 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 Coordinators, Study Managers, 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 manage 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 external partners and 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.
- 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. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- B.S. in a discipline relevant to the biological sciences.
- A minimum of 5 years of experience developing and managing electronic TMFs within the biotech/pharmaceutical industry is essential.
- 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.
- 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.