Associate II, TMF Operations
Pubblicato il 15-08-2026 - Altro in Roma
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate II, TMF Operations based in Italy.
Esperienza, qualifiche e soft skill: possiede tutti i requisiti per avere successo in questa occasione? Lo scopra qui sotto.
This role supports the accurate and compliant management of essential clinical trial documentation within a global Clinical Research Organization (CRO) environment. You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations. The position combines document quality control, records management, and collaboration with international clinical project teams. You will contribute directly to data integrity and inspection readiness across complex studies and sponsor portfolios. The role offers exposure to electronic TMF and document management systems while developing your understanding of clinical research operations. Success requires strong attention to detail, organization,
and the ability to manage multiple deadline-driven activities with accuracy. It is an excellent opportunity for an early-career professional seeking to build expertise in clinical documentation and TMF operations.
Accountabilities
Perform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices.
Process, review, classify, and resolve rejected Trial Master File documents across complex clinical studies and sponsor portfolios.
Manage essential documents in both electronic and hard-copy formats while maintaining accurate records and consistent document standards.
Prepare periodic TMF Quality Control checklists and coordinate their review with relevant project team members.
Conduct periodic TMF quality control activities to verify compliance with regulatory requirements, ICH GCP principles, sponsor expectati