Director of eTMF (0.5 FTE)

Raleigh, WV - USA

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities resourcing and Functional Service (FSP) solutions.

Join Our Team as a Director of eTMF (0.5 FTE) - home based in United States.

About this role

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).

Key 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.

Requirements:

Education & Certification

Bachelor of Science (BSc) degree in Life Sciences.
Veeva Vault eTMF SME Certification is required.

Experience

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.
Relevant therapeutic area experience

Technical & Regulatory Knowledge

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.
Skills & Competencies
Leadership: Demonstrated ability to lead complex programs manage people and solve high-level portfolio challenges.
Project Management: Advanced proficiency in managing timelines financial obligations and contractual deliverables.
Communication: Excellent verbal and written communication skills; ability to interact effectively with sponsors and internal stakeholders at the Executive level.
Travel: Willingness and ability to travel on occasion as required by the business or customer.

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden in the city of Lund. As a full-service global Contract Research Organization (CRO) we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.