Clinical Trial Manager

7 giorni fa

volpiano, Italia Advanced Clinical A tempo pieno

Clinical Trial Manager – Italy | Advanced Clinical (FSP Model)Oncology focusedAdvanced 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 CROsPreparing key study documents, including Monitoring Manuals, Study Operations Manuals, SDV Plans, and Laboratory ManualsDesigning and coordinating study materials such as CRFs, patient diaries, source documents, and participation cardsAssisting with protocol development and study reportsOverseeing monitoring activities to ensure compliance with GCP, SOPs, and study protocolsProviding direction and support to CRAsTracking patient enrollment, conducting site qualification/initiation/close-out activities, and supporting data management coordinationManaging study supplies and negotiating vendor contractsReviewing ICFs, CRFs, and study-related materialsPlanning and participating in investigator meetingsSupporting the data query processEnsuring regulatory compliance and maintaining an up-to-date Trial Master FileEssential Requirements:BA/BS degree or nursing qualification (science preferred)Minimum 5 years' experience in clinical studies, including at least 1 year of site managementPrevious monitoring or study coordination experience preferredStrong knowledge of GCP and SOPsUnderstanding of clinical study phasesAbility to work independently and within cross-functional teamsAdvanced proficiency in Word, Excel, and PowerPointExperience with electronic systems such as TMF, CTMS, Veeva Vault, Smartsheet, and SharePointStrong communication skillsWillingness 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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