TMF Lead I

🔥 1 hour ago

🇷🇸 Serbia – 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 (TMFs) in accordance with GCP, guidance documents, and Precision SOPs • Ensure timely, high-quality TMF document review, processing, quality review, setup, maintenance, finalization, and archival • Create and execute study TMF Plans and project TMF Document Indexes • Communicate TMF expectations, project-specific requirements, and changes to study teams • Attend and contribute to project kick-off, internal, external, and ad hoc meetings • Collaborate with Project Managers and Functional Leads to maintain inspection-ready TMFs • Identify TMF compliance risks, develop mitigation plans, and follow escalation processes • Monitor and report TMF health, metrics, trends, risks, and non-compliances • Serve as point of contact and subject matter expert for project audits and inspections • Provide TMF analytics and expertise to sponsors • Oversee periodic quality reviews and document processing 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 acknowledgment • Manage projects within sponsor eTMF systems • Monitor and report potential out-of-scope Records Management activities • Support and mentor less experienced TMF Leads

🎯 Requirements

• Bachelor’s degree (or its international equivalent) + 5 years of related experience, or equivalent combination of education, professional training and experience • Working knowledge of FDA and ICH/GCP regulations and guidelines • Working knowledge of relevant Precision SOPs and regulatory guidance • Ability to identify issues and escalate appropriately and effectively • Excellent organizational skills and time management • Ability to coordinate workload and meet established deadlines • Ability to manage competing priorities effectively • Strong self-motivation and attention to detail • Ability to work and plan independently and in a team environment • Professional verbal and written communication skills • Must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • AI opt-out request available during the application journey

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