TMF Lead

About Syneos Health 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. 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. 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 Summary The Trial Master File (TMF) Functional Lead provides strategic oversight and subject matter expertise for all TMF management activities from project award through final transfer. This role supports medium to high‑complexity global clinical trials, ensuring the delivery of high‑quality, inspection‑ready TMFs in alignment with regulatory requirements and contractual obligations. Responsibilities include TMF planning, document management, quality control, audit support, risk mitigation, and performance reporting. The TMF Functional Lead serves as a key contributor to cross‑functional project teams, driving operational excellence and compliance throughout the TMF lifecycle. Job Responsibilities Inspection Readiness Leadership Owns end‑to‑end accountability for TMF inspection readiness across assigned projects, ensuring documentation is audit‑ready at all times through proactive oversight and continuous engagement. Establishes and enforces TMF governance standards, embedding inspection readiness into daily operations and project milestones. Leads the identification, escalation, and resolution of TMF risks and issues, ensuring timely remediation and sustained compliance with regulatory expectations. Strategic Oversight & Execution Develops and executes TMF strategies aligned with project scope, timelines, and regulatory requirements, driving operational excellence and readiness for audits and inspections. Oversees TMF health through rigorous monitoring of KPIs, quality metrics, and submission timeliness; initiates corrective actions to address gaps and prevent inspection findings. Cross‑Functional Collaboration & Influence Partners with Project Leads, Functional Leads, and external stakeholders to ensure TMF documentation is submitted accurately and on time, reinforcing a culture of ownership and accountability. Serves as the TMF SME in internal and customer‑facing meetings, influencing strategic decisions through clear communication of TMF status, risks, and readiness posture. Audit & Compliance Representation Represents TMF Operations during audits and inspections, including qualification audits, providing expert guidance, documentation support, and real‑time issue resolution. Leads TMF‑focused meetings to review inspection readiness metrics, outstanding actions, and risk mitigation plans, ensuring alignment with project and regulatory expectations. Delivers TMF system training and onboarding to external users, enhancing inspection readiness through stakeholder education and system proficiency. Contributes to process improvement initiatives and departmental goals, advancing TMF operational maturity and audit preparedness across the organization. Training, Enablement & Continuous Improvement Delivers TMF system training and onboarding to external users, enhancing inspection readiness through stakeholder education and system proficiency. Contributes to process improvement initiatives and departmental goals, advancing TMF operational maturity and audit preparedness across the organization. Additional Responsibilities Performs other work‑related duties as assigned. Minimal travel may be required (up to 25%). 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. Equal Opportunity & EEO Statement 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. The Company is also committed to compliance with the EU Equality Directive and applies equal opportunity principles to the recruitment and employment of its employees. Applicants and employees of all genders, races, religions, nationalities, and sexual orientations are encouraged to apply. Tagline Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to: #J-18808-Ljbffr