Remote TMF Coordinator - Compliance & Documentation

Alimentiv

Warszawa

On-site

PLN 156,000 - 261,000

Full time

5 days ago
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Job summary

Alimentiv is seeking a detail-oriented TMF Coordinator to join the TMF Operations team. The role ensures the quality, completeness, and regulatory alignment of Trial Master File documentation for global trials.

You will maintain TMF structures, support inspection readiness, and collaborate with cross-functional stakeholders. This remote role offers two cross-listed positions and requires 1–3 years TMF experience in trials.

Qualifications

  • Bachelor’s degree in Life Sciences or related field is preferred.
  • 1-3 years of experience in clinical trials TMF management.
  • Working knowledge of eTMF platforms and regulatory requirements.
  • Solid understanding of clinical trial record management and quality standards.
  • Role supports remote work.

Responsibilities

  • Maintain TMF structure and ensure inspection-readiness and compliance.
  • File, classify, index, and apply version control to TMF documents.
  • Perform QC checks on TMF content and metadata.
  • Collaborate with study teams and support audits and inspections.
  • Assist in process improvements and standardization initiatives.

Skills

Detail-oriented
Organized
Communication
Stakeholder engagement
Analytical thinking
Problem solving

Education

Bachelor’s degree in Life Sciences

Tools

Veeva Vault
Phlexglobal
Trial Interactive
Excel
SharePoint

Job description

Alimentiv is seeking a detail-oriented TMF Coordinator to join the TMF Operations team. The role ensures the quality, completeness, and regulatory alignment of Trial Master File documentation for global trials.

You will maintain TMF structures, support inspection readiness, and collaborate with cross-functional stakeholders. This remote role offers two cross-listed positions and requires 1–3 years TMF experience in trials.

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