ppThis 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. /p pThis 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. /p h3Accountabilities /h3 ul liPerform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices. /li liProcess, review, classify, and resolve rejected Trial Master File documents across complex clinical studies and sponsor portfolios. /li liManage essential documents in both electronic and hard-copy formats while maintaining accurate records and consistent document standards. /li liPrepare periodic TMF Quality Control checklists and coordinate their review with relevant project team members. /li liConduct periodic TMF quality control activities to verify compliance with regulatory requirements, ICH GCP principles, sponsor expectations, SOPs, and industry best practices. /li liWork with electronic document management repositories and eTMF systems to review, index, process, and maintain essential clinical trial documentation.



/li liApply standardized document naming conventions and indexing requirements to ensure records are complete, accurate, searchable, and inspection-ready. /li liCollaborate regularly with project teams and colleagues across functions and geographies to resolve documentation issues and support efficient TMF processes. /li liMaintain high standards of accuracy while managing multiple detailed activities within established timelines. /li /ul h3Requirements: /h3 ul liUniversity degree preferred, ideally in Life Sciences or a related discipline. /li liUp to 1-2 years of relevant experience in TMF operations, records management, clinical research, CRO, pharmaceutical, or a related environment. /li liGeneral understanding of clinical research principles, clinical trial processes, and the purpose of Trial Master Files. /li liExperience or demonstrated ability in data collection, indexing, document editing, and applying standardized naming conventions. /li liAbility to work effectively with electronic document repositories, eTMF platforms, or similar document management systems, with willingness to develop further technical proficiency. /li liStrong written and verbal communication skills, with the ability to present information clearly, accurately, and concisely. /li liExceptional attention to detail and accuracy when handling highly structured and sensitive documentation. /li liStrong planning, prioritization, and organizational skills, with the ability to manage multiple tasks in a deadline-driven environment. /li liProficiency with Microsoft Word and Excel. /li liStrong interpersonal and collaboration skills, with the ability to work effectively in a fast-paced, changing,



and globally distributed environment. /li liA proactive, reliable, and quality-focused approach to work, with a commitment to following procedures and maintaining compliance. /li /ul h3Benefits: /h3 ul liOpportunity to build specialized experience in TMF operations and clinical research within a global CRO environment. /li liExposure to international clinical studies, sponsor portfolios, project teams, and industry best practices. /li liHands-on experience with electronic TMF and document management technologies. /li liOpportunities to collaborate with experienced professionals across clinical research and project teams. /li liA supportive and inclusive working environment that values collaboration, creativity, and professional development. /li liCareer development opportunities within a global organization focused on improving clinical research and patient outcomes. /li liAn environment committed to equal opportunity, diversity, inclusion, and respectful collaboration. /li liMeaningful work contributing to the quality, compliance, and integrity of clinical trials that can ultimately improve patients' lives. /li /ul pHow Jobgether works: /p pWe use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. /p pWe appreciate your interest and wish you the best! /p pData Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. /p p#LI-CL1 /p /p #J-18808-Ljbffr

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