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Trial Master File (TMF) Lead remote Mexico or Argentina

Syneos HealthTlalnepantla, Estado de México, Mexico

Hace 10 días

Tipo de contrato

Teletrabajo

Descripción del trabajo

Trial Master File (TMF) Lead remote Mexico or Argentina

Join to apply for the Trial Master File (TMF) Lead remote Mexico or Argentina role at 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.

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% '

Syneos Health 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.

Syneos Health is an Equal Employment Opportunity employer.

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