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TMF Lead/Senior TMF Lead

18 hours, 35 minutes ago
Serbia, Slovakia, Hungary, Poland, Romania
Full-time
Senior
Operations Specialist
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 73

Description

  • Create and execute study TMF plans and project-specific document indexes.
  • Communicate TMF expectations, changes, status, gaps, and escalations to study teams and stakeholders.
  • Maintain eTMF country, site, contact, and document requirement information.
  • Collaborate with Project Managers and Functional Leads to ensure timely, high-quality documentation and inspection readiness.
  • Monitor and report TMF health, trends, risks, compliance, and overall status.
  • Serve as the TMF subject matter expert for audits and inspections and support response development.
  • Conduct quarterly completeness and compliance checks and document findings.
  • Identify TMF training needs and provide team education and re-education.
  • Manage study closeout activities, including final submissions, query resolution, eTMF exports, and sponsor transfers.
  • Support process improvements, mentor junior Records Management staff, and serve as an eTMF system superuser.

Requirements

  • Four-year college degree or equivalent education and experience, preferably in business, science, or healthcare.
  • At least 3–4 years of TMF and/or eTMF experience, including 1+ year as a TMF Lead.
  • Fluency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Professional-level English proficiency.
  • Experience with Veeva Vault for document processing preferred.
  • Working knowledge of ICH-GCP, applicable regulatory guidance, and relevant SOPs, or the ability to acquire it.
  • Strong interpersonal, written, and verbal communication skills.
  • Ability to manage competing priorities and work independently and collaboratively.
  • Detail-oriented, self-motivated, professional, and reliable.
  • Ability to identify necessary escalations and communicate or implement resolutions.

Benefits

  • Remote work opportunity from Serbia, Poland, Hungary, Romania, or Slovakia.
  • Training and mentoring opportunities, including support for professional development in TMF and Records Management.
  • Equal opportunity employment and reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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