Clinical Trial Manager
hace 14 días
Clinical Trial Manager – Spain | 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.