Remote TMF Coordinator: Compliance & Documentation

Alimentiv; Poland; Hybrid; PLN 158,000 - 263,000; Full time

Benefits offered by this job

Bonus

Job summary

Alimentiv is seeking a detail-oriented TMF Coordinator to join the TMF Operations team. You will maintain the quality, completeness, and compliance of Trial Master File documentation across global regulatory standards to support inspection readiness and trial execution.

You will file and index documents in eTMF systems (Veeva Vault, Phlexglobal, Trial Interactive), apply ALCOA+ data integrity, and collaborate with cross-functional stakeholders to ensure timely, accurate TMF content.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 1–3 years experience in clinical trials TMF management.
• Working knowledge of eTMF platforms and regulatory requirements.
• Strong understanding of clinical trial record management and quality standards.
• Working remotely.

Responsibilities

• Maintain TMF structures and ensure compliance with ICH-GCP, FDA, EMA.
• File, classify, and index documents in the TMF with version control.
• Perform TMF QC checks and resolve missing or inconsistent records.
• Support inspection readiness, audits, and health checks.
• Collaborate with study teams to gather documentation and guide TMF requirements.

Skills

TMF management

Regulatory compliance

Documentation management

Quality checks

Remote collaboration

Education

Bachelor’s degree in Life Sciences or related field

Tools

Veeva Vault

Phlexglobal

Trial Interactive

Excel

SharePoint

Job description

Alimentiv is seeking a detail-oriented TMF Coordinator to join the TMF Operations team. You will maintain the quality, completeness, and compliance of Trial Master File documentation across global regulatory standards to support inspection readiness and trial execution.

You will file and index documents in eTMF systems (Veeva Vault, Phlexglobal, Trial Interactive), apply ALCOA+ data integrity, and collaborate with cross-functional stakeholders to ensure timely, accurate TMF content.