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TMF Coordinator

3 weeks, 1 day ago
United Kingdom, Germany, Hungary, Poland, Romania
Full-time
Junior
Manual QA Tester
Quality Assurance and Testing
Git
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 23

Description

  • Maintain paper and electronic TMF structures and essential clinical trial documentation.
  • File, classify, index, and manage documents using version control and naming conventions.
  • Perform quality control checks on TMF documents and metadata, resolving missing or inconsistent records.
  • Support TMF health checks, reporting metrics, audits, and inspection-readiness activities.
  • Investigate and resolve TMF gaps, discrepancies, filing issues, and system-related problems.
  • Collaborate with study teams and follow up on outstanding documentation.
  • Provide guidance on TMF requirements and processes.
  • Contribute to root cause analysis, process improvements, and standardization initiatives.

Requirements

  • 1–3 years of experience in clinical trial TMF management.
  • Bachelor’s degree in Life Sciences or a related field preferred.
  • Working knowledge of eTMF platforms and regulatory requirements.
  • Experience with eTMF and document management systems such as Veeva Vault, Phlexglobal, or Trial Interactive.
  • Knowledge of ICH-GCP, FDA, and EMA requirements and ALCOA+ data integrity principles.
  • Understanding of clinical trial record management and quality standards.
  • Proficiency with Microsoft Office tools, including Excel, Word, and SharePoint.
  • Strong attention to detail, organization, time management, communication, and problem-solving skills.
  • Ability to manage multiple priorities in a fast-paced, remote work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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