TMF Lead II; LATAM

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM!

Our TMF Lead II is responsible for supporting project teams in maintaining a high quality Trial Master File in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision standard operating procedures (SOPs). The TMF Lead II supports a range of studies across the Precision Medicine Group portfolio.

• Ensure that TMF document review and processing, periodic quality review, setup, maintenance, finalization and archival of study TMFs is completed timely and with a high level of quality.
• Create and execute the study TMF Plan and project TMF Document Index. Ensure the entire study team understands expectations, project‑specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team.
• Ensure that TMF documentation (e.g., TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF.
• Attend and contribute to project kick‑off meetings, internal or external meetings, and ad‑hoc meetings as needed to ensure the project team is aware of the status of the TMF, potential gaps and escalations.
• Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted timely and with high quality to maintain the TMF in an inspection‑ready state.
• Identify TMF risks and ensure they are documented, mitigated and monitored.
• Monitor and report on TMF health and metrics; escalate non‑compliances and potential issues to internal team and senior leadership as required.
• Identify trends, risks and overall status of the TMF and suggest mitigation strategies.
• Support audits and inspections, resolve findings, and participate in audit/inspection interviews with support and oversight from line management.
• Ensure that periodic quality reviews for assigned projects are initiated and performed by the quality review specialists and ensure proper documentation.
• Ensure that document review and processing for assigned projects is performed by the document specialists on a timely and consistent basis.
• Identify project team TMF training needs and provide or support re‑education.
• Manage close‑out activities of assigned studies, including defining timelines for final document submission, processing, close‑out of all outstanding queries, requesting the eTMF export from the vendor, transferring to the sponsor and collecting the acknowledgement of receipt.
• When needed, manage projects within the sponsor eTMF system.
• Monitor and report potential out‑of‑scope activities related to records management and communicate this to the TMF manager for support.
• Bachelor’s degree (or its international equivalent).
• A minimum of three years of related experience, or an equivalent combination of education, professional training and experience that provides the required knowledge, skills and abilities.
• Professional working proficiency in English.

• Established experience and fluency in the Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
• Experience with eTMF systems and vendors.
• Working knowledge of FDA and ICH/GCP regulations and guidelines.
• Demonstrates solid interpersonal skills.
• Ability to identify issues and escalates appropriately and effectively.
• Good organizational skills, time‑management, and ability to coordinate workload and meet deadlines.
• Demonstrates, or is able to be trained, and retain a working knowledge of ICH‑GCP, relevant Precision SOPs and regulatory guidance.
• Exhibits strong self‑motivation, is detail‑oriented and able to work and plan independently as well as in a team environment.
• Demonstrates professionalism, punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders.
• Communicates both verbally and in written form efficiently and professionally.
• Demonstrates values and a work ethic consistent with Precision values and company principles.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at  .