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 Operations, and project teams.

• Prepare and participate in internal and client meetings, including Program Reviews and Trusted Process events.

• Team Oversight & Mentorship

• Mentor TMF Leads and junior staff, fostering a culture of accountability and excellence.

• Support hiring, training, and task management of TMF Operations team members, as applicable.

• Actively participate in professional organizations to stay informed on best practices.

• Qualifications

• Bachelor's degree or equivalent required (scientific or technical discipline preferred).

• Minimum 5 years of clinical operations/development experience, with at least 3 years in TMF or records management.

• Prior experience as a TMF Manager in both outsourced and in-house settings.

• Expertise in Veeva eTMF platform and familiarity with automation tools.

• Strong understanding of global TMF regulations and clinical research guidelines.

• Proven leadership, training, and presentation skills.

• Experience supporting GCP audits and inspections.

• Excellent communication and collaboration skills across cross-functional teams.

• Ability to travel up to 25%, as needed.

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.