Clinical Trial Manager

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.