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Global study manager

A Coruña (15190)
Warman O'Brien
Publicada el 13 mayo
Descripción

Global Study Manager – Clinical OperationsRemoteFSP - Leading Global pharmaWe’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.Key Responsibilities- Support end-to-end delivery of global clinical studies from set-up through to close-out and CSR- Coordinate cross-functional teams and external partners to ensure efficient study execution- Manage global vendors (including CROs) to ensure performance against timelines, cost, and quality- Contribute to study documentation (e.G. ICFs, study agreements, vendor specifications)- Oversee study timelines, risks, and issue resolution, implementing mitigation plans where needed- Ensure inspection readiness through high-quality Trial Master File (TMF) management- Support study budget tracking, including vendor invoice reconciliation- Collaborate with Clinical Supply to ensure timely provision of investigational product and study materials- Contribute to investigator and study team meetings- Drive continuous improvement initiatives and operational excellence activitiesKey Requirements- Experience managing global clinical studies across multiple regions- Strong vendor management experience, including oversight of CROs and external providers- Proven ability to work cross-functionally with global stakeholders- Experience in risk management and escalation handling- Solid understanding of ICH GCP and clinical trial regulations- Background in Clinical Operations within a sponsor or CRO environmentWhat to do next:If this opportunity is of interest, please apply direct or share a copy of your CV to brook@warmanobrien.comnot what you’re looking for?Please contact Brook Bridges on +447488888638 for a confidential discussion about potential opportunities.

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Global study manager - warman o'brien (la coruña)
A Coruña
Warman O'Brien
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