Our partner is looking for a Associate II, TMF Operations based in Italy.
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. It is an excellent opportunity for an early-career professional seeking to build expertise in clinical documentation and TMF operations.
Perform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices.




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 expectations, SOPs, and industry best practices.
Work with electronic document management repositories and eTMF systems to review, index, process, and maintain essential clinical trial documentation.
Apply standardized document naming conventions and indexing requirements to ensure records are complete, accurate, searchable, and inspection-ready.
Collaborate regularly with project teams and colleagues across functions and geographies to resolve documentation issues and support efficient TMF processes.
University degree prefe

📌 Associate II, TMF Operations (Italia)
🏢 Altro
📍 Italia