TMF Lead II – LATAM

🔥 2 minutes ago

🌐 Brazil, Mexico – Remote

🇧🇷 Brazil – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 21%

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 Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 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 of study TMFs • 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 kickoff, internal, external, and ad hoc meetings • Collaborate with Project Managers and Functional Leads to maintain inspection-ready TMFs • 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 review/processing are completed for assigned projects • Identify TMF training needs and provide or support team re-education • Manage study close-out activities, including final submissions, query resolution, eTMF export, sponsor transfer, and receipt acknowledgment • 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 • Professional working proficiency in English • Established experience and fluency in Microsoft Office programs, including 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 established deadlines • Working knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, or ability to be trained and retain this knowledge • Ability to work and plan independently and in a team environment • Efficient and professional verbal and written communication • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• No benefits, perks, or compensation extras are specified in the posting

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