TMF Lead I

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

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.

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%)

Job Qualification -

• Should have 5+ Years of experience in TMF along with 2+ Years of years of experience as functional Lead.
• Should hold bachelor's degree in Lifescience.
• Prior experience in Veeva Vault Trial Master File (TMF) management strongly preferred.
• Proven experience leading or co-leading global clinical trial projects from initiation through close-out.
• Demonstrated ability to operate effectively in international and cross-functional environments.
• Strong leadership capabilities with a focus on aligning teams to achieve project milestones; exhibits persistence, decisiveness, and delivery-focused mindset.
• Experience within a Contract Research Organization (CRO) or related clinical research setting.
• Advanced critical thinking and problem-solving skills, with the ability to apply risk management principles to resolve complex issues.
• Excellent customer service orientation with strong presentation, interpersonal, negotiation, and communication skills.
• Highly organized with the ability to manage multiple priorities and meet deadlines across diverse projects.
• Detail-oriented and quality-driven, consistently delivering high-standard work.
• Adaptable and resilient, with the ability to work independently and collaboratively within a matrixed team environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and other communication tools.
• Solid understanding of clinical trial operations and a track record of contributing to project, departmental, and organizational goals.
• Familiarity with clinical project financial principles preferred.
• Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements preferred.

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.