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.