Integral Study Manager – Clinical OperationsRemoteFSP - Leading Global pharma Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación.
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We're supporting a leading global biopharmaceutical organisation in the search for an experienced Global Study Manager (GSM) to support the delivery of complex, global clinical trials.This role sits within Clinical Operations and plays a key part in ensuring studies are delivered on time, within budget, and to the highest quality standards, from protocol development through to study close-out and reporting.
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Key ResponsibilitiesSupport end-to-end delivery of global clinical studies from set-up through to close-out and CSRCoordinate cross-functional teams and external partners to ensure efficient study executionManage global vendors (including CROs) to ensure performance against timelines, cost, and qualityContribute to study documentation (e.g. ICFs, study agreements, vendor specifications)Oversee study timelines, risks, and issue resolution, implementing mitigation plans where neededEnsure inspection readiness through high-quality Trial Master File (TMF) managementSupport study budget tracking, including vendor invoice reconciliationCollaborate with Clinical Supply to ensure timely provision of investigational product and study materialsContribute to investigator and study team meetingsDrive continuous improvement initiatives and operational excellence activities
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Key RequirementsExperience managing global clinical studies across multiple regionsStrong vendor management experience, including oversight of CROs and xugodme external providersProven ability to work cross-functionally with global stakeholdersExperience in risk management and escalation handlingSolid understanding of ICH GCP and clinical trial regulationsBackground in Clinical Operations within a sponsor or CRO environment
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What to do next:If this opportunity is of interest, please apply direct or share a copy of your CV to
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