Teams at Alimentiv

Maintain inspection-ready Trial Master File documentation by filing, indexing, and quality-checking records in eTMF systems. Ensure compliance with ICH-GCP, FDA, EMA, and ALCOA+ requirements; investigate discrepancies, resolve documentation gaps, support audits and inspections, report TMF metrics, and collaborate with study teams on outstanding documentation and process improvements.

The TMF Associate is responsible for managing and maintaining the Trial Master File content throughout the study lifecycle, ensuring completeness, organization, and compliance with regulations while collaborating with study teams and providing training.

Maintain inspection-ready Trial Master File documentation by filing, classifying, indexing, and quality-checking clinical trial records. Ensure compliance with ICH-GCP, FDA, EMA, and ALCOA+ principles; resolve documentation gaps and system issues; support audits, inspections, health checks, reporting, and process improvements. Collaborate with study teams, provide TMF guidance, and follow up on outstanding documentation while managing multiple priorities remotely.