Director, TMF Management (Contract)

The Director, Trial Master File Management (Contract) will develop and lead a team responsible for management of inspection-ready Clinical Trial essential documents in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and Principia SOPs.

The Director is accountable for the timely preparedness of Trial Master Files (eTMFs), approval of TMF Management Plans, and maintaining routine oversight schedules to ensure archival and accessibility of all essential documents. The Director will be an organized leader accountable for ensuring cross functional tools to enable team members to determine comprehensiveness of documentation.

This in-office position is located in South San Francisco, CA and reports to the Sr. Director Development Operations.

Responsibilities

• Management of eTMF Essential Document staff responsible for ensuring accurate coding and filing of all essential study documents per DIA model structure, SOPs and ICH GCP
• Ensure establishment of SOP compliant study Trial Master File Plans and implementation of Naming and Filing Guide(s)
• Ensure Clinical Trial Master Files are maintained with an inspection-ready strategy

• Oversee implementation and management of eTMF applications including preparation and activation as well as maintenance of written instructions, guidelines and plans as they relate to eTMFs
• Oversee and ensure documented training of clinical document management staff and other internal or external eTMF users to eTMF system functionality
• Ensure Development Operations personnel are appropriately assigned eTMF User roles and permissions
• Monitor and evaluate study requirements to ensure eTMF structure is deployed in conjunction with clinical trial launch
• Plan, establish, monitor, and manage the overall eTMF vendor contracts and budgets in collaboration with Clinical Trial Managers, Contracts and Budgets and Finance and provide senior management with timely updates on changes in scope
• Oversee management of eTMF vendors including regular phone and face-to-face meetings as required
• Develop and review SOPs and guide the implementation of new SOPs, work instructions and departmental processes and forms, as needed, for continuous process improvement and support functional and organizational initiatives and to function as an advocate to ensure compliance with ICH GCP
• Ensure quality checks are performed as per SOPs and monitor staff progress in resolution of identified eTMF discrepancies
• Serve as subject matter expert on domestic/international documentation requirements
• Establish and oversee eTMF Key Performance Indicator metrics and corrective actions when needed

• Ensure routine distribution of eTMF status updates to Clinical Trial Managers for CRO follow-up and resolution

• Represent the clinical document management function both internally and externally, when applicable
• Oversee transfer and file-location mapping documentation of TMFs to/from CROs and partners, as applicable

• Work in collaboration with all applicable functional areas and external resources to resolve gaps in the eTMF

• Ensure document quality and compliance through active engagement with clinical study teams and management
• Participate as an SME during audits / inspections of Clinical Operations and the eTMF and interact with auditor/inspector to address queries
• Assist Clinical QA in site audit preparedness or performance
• Perform other tasks and assignments as needed and specified by management

Requirements

• Demonstrated knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation
• Demonstrated in-depth knowledge of clinical regulatory documentation requirements and understanding of records management best practices
• Thorough knowledge of all sections of the DIA Reference Model (current version) documents from various functional areas and their appropriate e/TMF filing requirements
• Thorough knowledge of eTMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals
• Analytical thinker with excellent problem-solving skills and the ability to support and adapt to changing priorities across multiple projects
• Demonstrated ability to successfully manage multiple projects from conception to completion, working collaboratively in a team environment.
• Proficiency in developing and delivering educational materials, both written and oral
• Detail oriented
• Demonstrated understanding of the clinical drug development process and clinical trial methodology
• Demonstrated leadership ability including ability to influence without management authority and interface effectively with all levels, including senior management
• Self-directed and collaborative while building strong working relationships with co-workers of various backgrounds and expertise across multiple departments
• Ability function at a high level, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Preferred Education: B.S. in library sciences or B.A./advanced degree in biological science or life sciences discipline
• Preferred Experience: At least 10 years' experience in TMF management roles, including international studies, with 5 years' experience managing multiple direct reports
• Preferred Computer Skills: Experience with eTMF applications such as Veeva Vault, Trial Interactive, and Phlex Global. Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint and Microsoft Project.

Principia Biopharma is an equal opportunity employer.