--- title: 'TMF Lead II (LATAM) at Precision for Medicine' canonical: 'https://feeny.ai/job/tmf-lead-ii-latam-precision-for-medicine-brazil-mexico-jkdkq087sgh6' type: 'job' last_seen: '2026-09-14' --- # TMF Lead II (LATAM) at Precision for Medicine - **Company:** Precision for Medicine - **Location:** Brazil / Mexico - **Work type:** remote - **Posted:** 2026-06-18 - **Last confirmed live:** 2026-09-14 - **Apply:** https://job-boards.greenhouse.io/pfm/jobs/6093245004 ## Job description 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 Files 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. Responsibilities: - Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high level of quality - Create and execute the study TMF Plan and project TMF Document Index. Ensure 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, project 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 in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state - Ensure that TMF Risks are identified and appropriately documented and mitigated - Monitor and report on TMF Health and Metrics and 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 and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management - Ensure that Periodic Quality Review for assigned projects is 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 team re-education - Manage the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfer to the sponsor and collect the Acknowledgement of Receipt - Where needed, manage projects within the Sponsor eTMF System - Monitor and report potential out of scope activities related to Records Management and communicate this to TMF manager for support Minimum Education & Experience: - Bachelor’s degree (or its international equivalent) - A minimum of 3 years of related experience Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job. - Professional working proficiency in English Knowledge, Skills, and Competencies: - Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint) - Experience with eTMF systems and vendors - Working knowledge of FDA & ICH/GCP regulations and guidelines - Demonstrates solid interpersonal skills - Ability to identify issues and escalate appropriately and effectively - Good organizational skills, time management, and ability to coordinate workload and meet established deadlines - Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and 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, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders - Communicates both verbally and in written form in an efficient and professional manner - Demonstrates values and a work ethic consistent with Precision Values and Company Principles ## #LI-AG2 #LI-REMOTE Any data provided as a part of this application will be stored in accordance with our [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0). 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 myHR@precisionmedicinegrp.com. Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action. ## About Precision for Medicine ## Company Overview - **One-liner**: Precision for Medicine is a global clinical research organization (CRO) and laboratory services provider specialized in accelerating the development of precision therapies for oncology, rare disease, and other complex conditions. - **Entity Type**: Private – subsidiary of Precision Medicine Group (a private holding company) - **Headquarters**: Not explicitly stated in sources; likely around the Washington D.C./Maryland area (Precision Medicine Group HQ is in Bethesda, MD). The company operates globally with labs in North America and Europe. - **Founded**: 2012 (company began), but the team has over 25 years of clinical trial experience - **Founders**: Not publicly disclosed on provided sources; leadership includes a founder role but name not given. ## Core Business - **Primary industries**: Contract Research Organization (CRO) services, central laboratory services, biospecimen solutions, data intelligence for clinical development. - **Target customers**: Biotechnology and pharmaceutical companies developing precision medicines, especially in oncology and rare disease (B2B, mid-to-large pharma). - **Mission/purpose**: “Bringing life-changing therapies to patients by integrating laboratory expertise, clinical trial excellence, and data intelligence to deliver critical insights into patient biology.” ## Products & Services - **Global CRO Services**: Full-service clinical trial management with a focus on early- and late-phase development, regulatory support, project management, and site startup. Over 75% of trials are in oncology. - **Global Laboratory Services**: Translational and biomarker sciences, including specialty labs for genomics, flow cytometry, molecular diagnostics, and central lab testing. Operates 5 specialty labs in the US and Europe. - **Biospecimens**: Access to over 11 million tissue, cellular, and biofluid specimens for research. - **Data Intelligence**: AI-enabled data ecosystem for sample management, biomarker analysis, biostatistics, and decision support (includes a conversational AI virtual assistant). - **Diagnostics and Companion Diagnostics (CDx)**: Development and commercialization of diagnostic tests aligned with therapies. ## Market Standing - **Valuation / Market Cap**: Not publicly disclosed (part of private Precision Medicine Group). - **Key Metric**: ~3,500 employees; 2,500+ clinical trial and lab projects; 70% of clinical trials in oncology; 25+ years of combined experience. - **Notable Investors/Partners**: Sources mention “$30B in investments raised for biotech in the last 5 years” (general biotech investment, not specific to Precision). No specific lead investors listed; backed by private equity (Precision Medicine Group is owned by institutional investors). - **Growth Signals**: Awarded the 2025 Fierce Biotech CRO Award for Innovative Solutions in Drug Development. Active hiring with 129 job openings globally (as of July 2026). Strong remote/hybrid work options across many roles. ## Competitive Advantages - **Integrated CRO + Lab + Data**: One organization covering the full spectrum from biospecimens to late-phase trials, reducing inefficiencies of working with separate vendors. - **Specialization in complex indications**: Deep expertise in oncology and rare disease, where protocols are highly complex. - **Right-sized CRO model**: Assigns employees to no more than 2–3 trials at a time, offering more attention than large “Big Five” CROs (positioned as “antidote to Big Five Fatigue”). - **AI-enabled data intelligence**: Unified ecosystem with conversational AI to extract insights from siloed data. ## Strategic Focus - Continue expanding capabilities in precision medicine development, particularly in early-phase oncology and rare disease. - Leverage data intelligence and AI to improve trial efficiency and patient matching. - Scale global clinical operations (recent push into Asia Pacific, Latin America, and Eastern Europe). ## Why Work Here - **Culture**: Employee-driven mission “to help patients get access to innovative treatments.” Collaboration across functions is emphasized, with a focus on complex and impactful therapies. - **Work environment**: Strong remote/hybrid options – job postings span remote roles in the US, Canada, Europe, Asia, and Latin America. Offices and labs exist in multiple countries. - **Perks & growth**: Not explicitly detailed, but the company invests in career development (e.g., roles from CRA to Director level). 25 years of history and a growing global footprint indicate stability and upward mobility. - **Engineering & science culture**: Teams include clinical scientists, data engineers, lab professionals, and operations – a blend of deep science and tech. ## Sources 1. [Precision for Medicine – Homepage](https://www.precisionformedicine.com/) 2. [Precision for Medicine – Our Story](https://www.precisionformedicine.com/about-us/our-passion/) 3. [Precision for Medicine – Leadership](https://www.precisionformedicine.com/about/leadership) 4. [Precision for Medicine – Careers (Greenhouse)](http://job-boards.greenhouse.io/pfm) 5. [Precision for Medicine – LinkedIn](https://www.linkedin.com/company/precision-for-medicine) ## Other roles at Precision for Medicine - [Clinical Trial Manager](https://feeny.ai/job/clinical-trial-manager-precision-for-medicine-australia-t3ys5d81218q) — Australia - [Senior Manager, Clinical Operations - Clinical Process Owner](https://feeny.ai/job/senior-manager-clinical-operations-clinical-process-owner-precision-for-t4eva5xvtr29) — Poland - [Senior Clinical Project Manager/Clinical Project Manager](https://feeny.ai/job/senior-clinical-project-manager-clinical-project-manager-precision-for-medicine-qrkh5nddsa81) — Australia / Singapore / South Korea / Taiwan - [Kit Production Technician I](https://feeny.ai/job/kit-production-technician-i-precision-for-medicine-frederick-md-a0byjwzjbcca) — Frederick MD, United States - [Non-Registered Histotechnician](https://feeny.ai/job/non-registered-histotechnician-precision-for-medicine-winston-salem-nc-t1vqqktwqayx) — Winston-Salem NC, United States - [Biorepository Technician I](https://feeny.ai/job/biorepository-technician-i-precision-for-medicine-winston-salem-nc-ac4h0gkbjtdy) — Winston-Salem NC, United States - [Biorepository Technician II](https://feeny.ai/job/biorepository-technician-ii-precision-for-medicine-frederick-md-n35cr3n32kzb) — Frederick MD, United States - [Senior Regulatory and Start Up Specialist (Argentina)](https://feeny.ai/job/senior-regulatory-and-start-up-specialist-argentina-precision-for-medicine-xy9668p2cfcp) — Argentina - [Senior Clinical Data Engineer (LATAM)](https://feeny.ai/job/senior-clinical-data-engineer-latam-precision-for-medicine-argentina-brazil-1tat1ce2c0cy) — Argentina / Brazil / Colombia / Mexico - [Senior Manager, Clinical Operations - Clinical Process Owner](https://feeny.ai/job/senior-manager-clinical-operations-clinical-process-owner-precision-for-j11kqphtht2d) — Belgium / France / Germany / Hungary / Italy / Netherlands / Romania / Serbia / Slovakia / Spain / United Kingdom