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Clinical trial manager

Padova
Advanced Clinical
Pubblicato il 10 dicembre
Descrizione

PbClinical Trial Manager – Italy | Advanced Clinical (FSP Model) /b /ppOncology focused /ppbr/ppAdvanced 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. /ppbr/ppbResponsibilities include: /b /ppbr/pulliManaging external vendors and CROs /liliPreparing key study documents, including Monitoring Manuals, Study Operations Manuals, SDV Plans, and Laboratory Manuals /liliDesigning and coordinating study materials such as CRFs, patient diaries, source documents, and participation cards /liliAssisting with protocol development and study reports /liliOverseeing monitoring activities to ensure compliance with GCP, SOPs, and study protocols /liliProviding direction and support to CRAs /liliTracking patient enrollment, conducting site qualification/initiation/close-out activities, and supporting data management coordination /liliManaging study supplies and negotiating vendor contracts /liliReviewing ICFs, CRFs, and study-related materials /liliPlanning and participating in investigator meetings /liliSupporting the data query process /liliEnsuring regulatory compliance and maintaining an up-to-date Trial Master File /li /ulpbr/ppbEssential Requirements: /b /ppbr/pulliBA/BS degree or nursing qualification (science preferred) /liliMinimum 5 years' experience in clinical studies, including at least 1 year of site management /liliPrevious monitoring or study coordination experience preferred /liliStrong knowledge of GCP and SOPs /liliUnderstanding of clinical study phases /liliAbility to work independently and within cross-functional teams /liliAdvanced proficiency in Word, Excel, and PowerPoint /liliExperience with electronic systems such as TMF, CTMS, Veeva Vault, Smartsheet, and SharePoint /liliStrong communication skills /liliWillingness to travel 10–20% /li /ulpbr/ppTo 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. /p

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