Remote TMF Operations Specialist

Alimentiv; Windsor; On-site; GBP 31,000 - 52,000; Full time

Benefits offered by this job

Bonus

Job summary

Alimentiv is seeking a detail-oriented TMF Coordinator to join our TMF Operations team. You will ensure quality, completeness, and compliance of TMF documentation to ICH-GCP, FDA, and EMA standards, supporting inspection readiness and clinical trial execution.

You will collaborate with cross-functional stakeholders, file and index documents, manage eTMF systems, and maintain data integrity using ALCOA+ principles. This role is remote with opportunities across multiple countries.

Qualifications

• Bachelor’s degree in Life Sciences or related field preferred.
• 1–3 years experience in TMF management for clinical trials.
• Working knowledge of eTMF platforms and regulatory requirements.

Responsibilities

• Maintain TMF structures (paper and electronic) and ensure inspection readiness.
• File, classify, and index TMF documents with proper version control.
• Coordinate with cross-functional teams to obtain missing documents and resolve gaps.
• Perform QC checks on TMF documents and metadata to ensure accuracy and timeliness.
• Support audit readiness activities and TMF health metrics.

Skills

Attention to detail

Organization

Time management

Communication

Stakeholder engagement

Analytical thinking

Problem solving

Education

Bachelor’s degree in Life Sciences

Tools

Veeva Vault

Phlexglobal

Trial Interactive

Microsoft Office

Job description

Alimentiv is seeking a detail-oriented TMF Coordinator to join our TMF Operations team. You will ensure quality, completeness, and compliance of TMF documentation to ICH-GCP, FDA, and EMA standards, supporting inspection readiness and clinical trial execution.

You will collaborate with cross-functional stakeholders, file and index documents, manage eTMF systems, and maintain data integrity using ALCOA+ principles. This role is remote with opportunities across multiple countries.