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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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