TMF Program Manager - Sponsor Dedicated (Remote, U.S. 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

TMF Program Manager - Sponsor Dedicated (Remote, U.S. or UK)

Lead innovation. Drive compliance. Elevate TMF excellence.

We are seeking a seasoned TMF Program Manager to provide sponsor-dedicated leadership and oversight of Trial Master File (TMF) activities across a global portfolio of clinical studies. This high-impact position combines deep technical expertise in Veeva eTMF with strategic vision-driving innovation, compliance, and operational excellence across outsourced and hybrid study models.

If you excel at transforming TMF operations through automation, technology, and strong stakeholder collaboration, this is an opportunity to make a real difference.

What you will do:

Strategic Oversight & Leadership

• Lead TMF operations across a portfolio of approximately 58 ongoing global studies in outsourced, hybrid, and internal models.

• Ensure TMF compliance, completeness, and audit-readiness in alignment with ICH-GCP E6-R3, 21 CFR Part 11, and sponsor SOPs.

• Serve as the TMF subject matter expert-partnering with CROs, vendors, and internal teams to ensure consistency and quality across all programs.

Technology, Innovation & Optimization

• Act as a Veeva eTMF expert, leveraging automation and AI tools such as bots and auto-naming to enhance efficiency and data quality.

• Evaluate new system capabilities and influence platform enhancements to drive continuous improvement.

• Stay current on TMF technology, regulatory expectations, and industry best practices to guide innovation and risk management decisions.

Training, Mentorship & Team Development

• Develop and Deliver engaging TMF training sessions for internal teams, CRO partners, and vendors.

• Mentor and guide junior TMF staff, fostering confidence, accountability, and operational excellence.

• Promote a culture of continuous learning and process improvement across the TMF function.

Audit & Inspection Readiness

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

• Provide proactive TMF guidance to ensure study documentation meets global standards and is inspection-ready at all times.

Metrics, Quality & Governance

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

• Develop, maintain, and present TMF Health Reports and KPIs to track progress and performance.

• Partner with study teams to ensure vendor governance, timely delivery, and adherence to TMF specifications and contractual obligations.

Financial & Operational Support (supporting role)

• Collaborate with Study Teams and BizOps on TMF-related budgeting and forecasting for outsourced activities.

• Provide input into CRO Statements of Work and long-range planning for TMF deliverables.

What You'll Bring:

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

• 5+ years of experience in clinical operations/development, including 3+ years of direct TMF management (manager-level).

• Demonstrated expertise in Veeva eTMF, specifically in automation and AI-driven TMF capabilities and how the industry is utilizing these.

• Strong understanding of global TMF regulations, audit requirements, and best practices.

• Proven success leading TMF operations across outsourced and hybrid study models.

• Exceptional leadership, training, and presentation skills-able to mentor others and influence cross-functional teams.

• Experience supporting regulatory inspections and GCP audits.

• Forward-thinking mindset, with the ability to evaluate and implement new technologies for TMF optimization.

Why You'll Love This Role:

You'll lead sponsor-dedicated TMF operations at a global scale, influencing both technology and process excellence. Your expertise will shape TMF strategy, strengthen compliance across studies, and help set new standards in inspection readiness and operational efficiency.

Ready to lead innovation in TMF management?

Join us as a Sponsor-Dedicated TMF Program Manager and make your mark in the next evolution of clinical operations.

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.

http://www.syneoshealth.com

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.