[All remote jobs](https://jobicy.com/jobs.md)[![Precision Medicine Group logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/f1277044-221.jpg)](https://jobicy.com/company/precision-medicine-group.md)[Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md) # TMF Lead II (LATAM) AI Summary TMF Lead II supports clinical study teams by maintaining complete, high-quality, inspection-ready Trial Master Files across the Precision Medicine Group portfolio. The role owns TMF planning, document indexing, quality reviews, risk tracking, metrics, escalation, and close-out documentation. It collaborates closely with project managers, functional leads, document specialists, quality reviewers, sponsors, and senior leadership. Success requires hands-on eTMF experience, strong knowledge of ICH-GCP and FDA requirements, careful document control, and professional English communication. This remote role is specifically listed for candidates in Brazil or Mexico.[Apply for this job](#job-application)[View company](https://jobicy.com/company/precision-medicine-group.md)ShareRemote from[Brazil](https://jobicy.com/job-region/brazil.md), [Mexico](https://jobicy.com/job-region/mexico.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished8 Nov 2026Apply before8 Dec 2026Listing views39Application actions3Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. Opportunity details ## About this role. 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](https://jobicy.com/company/precision-medicine-group.md) 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](mailto: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](mailto:myHR@precisionmedicinegrp.com) so we can investigate and take appropriate action. Candidates must be legally authorized to work in the country of employment without employer sponsorship. Show more [Apply now >](https://jobicy.com/jobs/159721-tmf-lead-ii-latam.md) > Annual salary information is not provided for this position. Explore salary ranges for similar roles in our [Salary Directory ›](https://jobicy.com/salaries.md) * ![Upload CV](data:image/svg+xml;base64,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) ### Upload your resume now To unlock remote work opportunities and be discovered by global employers. This job listing has been manually reviewed by the Jobicy Trust & Safety Team for compliance with our posting guidelines, including verification of the company's legitimacy, accuracy of job details, clarity of remote work policy, and absence of misleading or fraudulent content. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 4/5IndependentCollaborative AI insightThe position manages regulated clinical-trial documentation where omissions, quality issues, and delayed filings can create audit or inspection risk. It requires independent prioritization across studies while coordinating multiple stakeholders and escalating compliance issues promptly. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Highly competitive$75,000US market range (per year)$55k–$90k0$99.00k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. No employer compensation was disclosed. The annual period and USD market estimate are inferred for a mid-level remote clinical TMF leadership role; these figures are AI estimates rather than verified compensation data. ## Core skills Skills and capabilities most closely associated with this opportunity. [Trial Master File management](https://jobicy.com/jobs?search_keywords=Trial%20Master%20File%20management.md)[eTMF systems](https://jobicy.com/jobs?search_keywords=eTMF%20systems.md)[ICH-GCP compliance](https://jobicy.com/jobs?search_keywords=ICH-GCP%20compliance.md)[FDA regulations](https://jobicy.com/jobs?search_keywords=FDA%20regulations.md)[Clinical trial documentation](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20documentation.md)[Quality review](https://jobicy.com/jobs?search_keywords=Quality%20review.md)[Inspection readiness](https://jobicy.com/jobs?search_keywords=Inspection%20readiness.md)[TMF risk management](https://jobicy.com/jobs?search_keywords=TMF%20risk%20management.md)[Document indexing](https://jobicy.com/jobs?search_keywords=Document%20indexing.md)[Clinical study close-out](https://jobicy.com/jobs?search_keywords=Clinical%20study%20close-out.md)[Audit support](https://jobicy.com/jobs?search_keywords=Audit%20support.md)[Microsoft Excel](https://jobicy.com/jobs?search_keywords=Microsoft%20Excel.md)[Stakeholder communication](https://jobicy.com/jobs?search_keywords=Stakeholder%20communication.md)[Project coordination](https://jobicy.com/jobs?search_keywords=Project%20coordination.md) Sample interview questionsHow do you ensure a Trial Master File remains inspection-ready throughout a study?I establish a clear TMF plan and document index at study start, define filing expectations with the project team, and monitor completeness and timeliness through periodic quality reviews and metrics. I document gaps, assign owners, follow up on corrective actions, and escalate material risks early. Describe how you would handle recurring late or incomplete TMF submissions from a functional team. I would first analyze the trend to identify the root cause, such as unclear ownership, missing training, or process barriers. I would discuss the issue with the functional lead, agree on a corrective plan and deadlines, provide targeted re-education where needed, and escalate if the risk to TMF quality persists. What experience do you have with ICH-GCP requirements in TMF management? I apply ICH-GCP principles by ensuring essential documents are attributable, complete, current, appropriately filed, and readily retrievable. I use these requirements to assess filing quality, identify compliance risks, and prepare records for audits and regulatory inspections. How would you manage TMF close-out for an assigned clinical study? I would create a close-out timeline, reconcile the TMF against the expected document index, resolve outstanding queries, and confirm final document processing. I would coordinate the eTMF export with the vendor, arrange transfer to the sponsor, and retain the acknowledgement of receipt and all required close-out documentation. How do you communicate TMF risks and metrics to project stakeholders? I present concise, actionable updates that distinguish routine gaps from material compliance risks. I explain the impact, responsible owner, expected resolution date, and recommended mitigation, adapting the level of detail for project teams, functional leads, and senior leadership. Next step ## Apply now. Follow the employer’s application method and review Jobicy’s safety guidance before sharing personal information. 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