TMF Lead II – LATAM

🔥 6 minutes ago

🌐 Brazil, Mexico – Remote

🇧🇷 Brazil – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Support project teams in maintaining high-quality Trial Master Files in accordance with GCP, guidance documents, and Precision SOPs • Complete TMF document review and processing, periodic quality review, setup, maintenance, finalization, and archival • Create and execute study TMF Plans and project TMF Document Indexes • Ensure study teams understand TMF expectations and communicate changes to TMF Plans or Indexes • File TMF documentation, including TMF Plans, TMF Indexes, and Periodic Quality Review documentation • Attend and contribute to project kick-off, internal, external, and ad hoc meetings • Collaborate with Project Managers and Functional Leads to maintain an inspection-ready TMF • Identify, document, and mitigate TMF risks • Monitor and report TMF health and metrics; escalate non-compliances and potential issues • Identify trends, risks, and overall TMF status and suggest mitigation strategies • Support audits and inspections, finding resolutions, and audit/inspection interviews • Ensure Periodic Quality Reviews and document processing are completed by assigned specialists • Identify TMF training needs and provide or support team re-education • Manage study close-out activities, including final submissions, query closure, eTMF export, sponsor transfer, and receipt acknowledgement • Manage projects within the Sponsor eTMF System where needed • Monitor and report potential out-of-scope Records Management activities to the TMF manager

🎯 Requirements

• 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 required knowledge, skills, and abilities • Professional working proficiency in English • Established experience and fluency in Microsoft Office (Outlook, Word, Excel and PowerPoint) • Experience with eTMF systems and vendors • Working knowledge of FDA and ICH/GCP regulations and guidelines • Ability to identify issues and escalate appropriately and effectively • Good organizational skills, time management, workload coordination, and ability to meet deadlines • Working knowledge of ICH-GCP, Precision SOPs, and relevant regulatory guidance, or ability to be trained and retain this knowledge • Ability to work and plan independently and in a team environment • Professional verbal and written communication • Values and work ethic consistent with Precision Values and Company Principles

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