Clinical Trial Manager
Descrizione dell'offerta
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.