TMF Coordinator

Alimentiv is seeking a detail-oriented and highly organized TMF Coordinator to join our TMF Operations team. In this role, you will be responsible for maintaining the quality, completeness, and compliance of Trial Master File documentation in alignment with global regulatory requirements and company standards to ensure clinical trial inspection readiness.

Key responsibilities

• Maintain in-depth knowledge of TMF structures and ensure compliance with ICH-GCP, FDA, and EMA regulations.
• Accurately file, classify, and index documents within the eTMF system while adhering to version control and naming conventions.
• Perform rigorous quality control checks on TMF documents and metadata to identify and resolve missing or inconsistent records.
• Investigate and resolve TMF gaps and discrepancies while contributing to process improvements and standardization initiatives.
• Collaborate with study teams to follow up on outstanding documentation and provide clear guidance on TMF requirements.

Requirements

• Bachelor’s degree in Life Sciences or a related field is preferred.
• 1-3 years of professional experience in clinical trials TMF management.
• Working knowledge of eTMF platforms and a strong understanding of regulatory requirements.
• Excellent organizational, time management, and analytical problem-solving skills.
• Strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.

What we offer

• The opportunity to work in a fully remote environment within a global clinical research organization.
• Professional development and exposure to industry-leading eTMF systems and document management processes.
• A collaborative team culture focused on quality, compliance, and continuous improvement in clinical trial execution.