TMF Program Manager, Home based, can be located in US or UK

TMF Program Manager, Home based, can be located in US or UK

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

We are seeking a seasoned TMF Program Manager to lead and oversee Trial Master File (TMF) activities across a diverse global portfolio of clinical studies. This role requires deep expertise in end-to-end TMF management, particularly within the Veeva eTMF platform, and a strategic mindset to drive innovation, compliance, and operational excellence. The ideal candidate will be a collaborative leader with strong technical acumen, capable of influencing decisions and mentoring teams to ensure TMF integrity and audit readiness.

• Key Responsibilities

  TMF Oversight & Strategy

• Lead TMF activities across global clinical studies, including outsourced and hybrid models.

• Ensure TMF compliance, completeness, and audit-readiness across CROs and internal teams.

• Develop portfolio-level TMF plans and training templates.

• Evaluate and mitigate TMF risks across assigned portfolios, escalating as needed.

• Technology & Innovation

• Manage access and training for company and client eTMF technologies.

• Implement and optimize new system capabilities, including automation tools (e.g., bots, auto-naming in Veeva).

• Stay current with industry trends and regulatory expectations to influence platform enhancements.

• Training & Development

• Present and deliver TMF-related training to internal teams, clients, and vendors.

• Provide continual learning opportunities and development goals for study team members.

• Coordinate onboarding and guidance for new staff and TMF department personnel.

• Audit & Inspection Readiness

• Prepare and participate in GCP audits and inspections (FDA, EMA, MHRA, PMDA).

• Provide TMF guidance to study teams to ensure documentation meets global regulatory standards (ICH-GCP E6-R3, 21 CFR Part 11).

• Metrics & Data Quality

• Oversee TMF data quality, structure, and completeness in applicable systems.

• Develop, maintain, and present key operational metrics and TMF Health KPIs.

• Collaborate with clients to establish portfolio progress and business metrics.

• Financial Support (Support Role)

• Support study teams and BizOps in financial forecasting and budgeting for outsourced TMF activities.

• Provide input on TMF-related items in CRO SOWs and long-range planning.

• Vendor Management & Governance

• Oversee CRO performance metrics and contractual timelines for outsourced TMF activities.

• Collaborate with study teams on vendor governance and ensure alignment with TMF specifications.

• Liaise with TMF Leads Management to ensure consistency in oversight and KPI tracking across portfolios.

• Communication & Collaboration

• Maintain effective communication with clients, Strategic Alliance Management, TMF Opera