Clinical Trial Manager

2 settimane fa

Italy Advanced Clinical A tempo pieno

Clinical Trial Manager – Italy | Advanced Clinical (FSP Model) Oncology focused Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience. Responsibilities include: Managing external vendors and CROs Preparing key study documents, including Monitoring Manuals, Study Operations Manuals, SDV Plans, and Laboratory Manuals Designing and coordinating study materials such as CRFs, patient diaries, source documents, and participation cards Assisting with protocol development and study reports Overseeing monitoring activities to ensure compliance with GCP, SOPs, and study protocols Providing direction and support to CRAs Tracking patient enrollment, conducting site qualification/initiation/close-out activities, and supporting data management coordination Managing study supplies and negotiating vendor contracts Reviewing ICFs, CRFs, and study-related materials Planning and participating in investigator meetings Supporting the data query process Ensuring regulatory compliance and maintaining an up-to-date Trial Master File Essential Requirements: BA/BS degree or nursing qualification (science preferred) Minimum 5 years' experience in clinical studies, including at least 1 year of site management Previous monitoring or study coordination experience preferred Strong knowledge of GCP and SOPs Understanding of clinical study phases Ability to work independently and within cross-functional teams Advanced proficiency in Word, Excel, and PowerPoint Experience with electronic systems such as TMF, CTMS, Veeva Vault, Smartsheet, and SharePoint Strong communication skills Willingness to travel 10–20% To express interest or learn more about this opportunity, please get in touch. Advanced Clinical offers a collaborative environment where your contributions directly support the success of innovative clinical research.

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