Director of eTMF (0.5 FTE)

TFS HealthScience • Raleigh, NC

2d • Remote

About The Position

As part of our CDS Ophthalmology Trail Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Director of eTMF is a strategic leadership role responsible for the comprehensive management and clinical document integrity across a designated portfolio of TFS clinical programs. Serving as a primary Subject Matter Expert (SME) in Veeva Vault, the Director acts as the central point of contact for sponsor leadership and internal stakeholders. This role provides high-level program oversight across all current and incoming protocols, ensuring that the portfolio adheres to TFS SOPs, regulatory requirements, and financial/contractual obligations while consistently meeting established Key Performance Indicators (KPIs).

Requirements

• Bachelor of Science (BSc) degree in Life Sciences.
• Veeva Vault eTMF SME Certification is required.
• Minimum of 9 years of relevant experience in the pharmaceutical, biotechnology, or CRO industry.
• Proven track record of increasing responsibility, including line management of diverse clinical documentation or project teams.
• Deep expertise in Veeva Vault eTMF architecture and functionality.
• Expert-level knowledge of global regulations and guidelines, including ICH E6 (GCP) and 21 CFR Part 11.
• Strong understanding of the DIA TMF Reference Model.
• Demonstrated ability to lead complex programs, manage people, and solve high-level portfolio challenges.
• Advanced proficiency in managing timelines, financial obligations, and contractual deliverables.
• Excellent verbal and written communication skills; ability to interact effectively with sponsors and internal stakeholders at the Executive level.
• Willingness and ability to travel on occasion as required by the business or customer.

Nice To Haves

• Relevant therapeutic area experience

Responsibilities

• Strategic Oversight: Provide a comprehensive portfolio-level overview of the eTMF across all active and incoming protocols within the assigned account.
• Executive Liaison: Lead regular program meetings and serve as the primary escalation point and strategic contact for sponsor-side eTMF leadership.
• Performance Analytics: Conduct TMF metrics reviews and perform portfolio-level KPI trend analysis to identify and mitigate systemic signals or risks.
• Reporting: Draft, finalize, and circulate Executive Portfolio Summaries and maintain robust documentation for stakeholder communications and decision logs.
• Study Health & Compliance: Perform cross-study health reviews and conduct routine audit/inspection readiness spot checks to ensure "Inspection Ready" status at all times.
• Meeting Leadership: Prepare TMF strategy for program meetings, lead issue-resolution breakouts, and manage follow-up summaries, including the tracking of actions and owners.
• Resource Coordination: Coordinate with protocol-specific TMF leads to ensure alignment between sponsor-specific requirements and TFS global standards.
• Vendor & SLA Management: Oversee external eTMF vendors (e.g., Meimeo, GSB, etc.) to ensure Service Level Agreements (SLAs) are met regarding document processing, quality, and timelines.

Benefits

• We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.

What This Job Offers

• Job Type: Part-time
• Career Level: Director
• Number of Employees: 501-1,000 employees