Descripción de la oferta
pbGlobal Study Manager – Clinical Operations /b /ppRemote /ppFSP - Leading Global pharma /ppbr/ppWe’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. /ppThis 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. /ppbr/ppbKey Responsibilities /b /pulliSupport end-to-end delivery of global clinical studies from set-up through to close-out and CSR /liliCoordinate cross-functional teams and external partners to ensure efficient study execution /liliManage global vendors (including CROs) to ensure performance against timelines, cost, and quality /liliContribute to study documentation (e.g. ICFs, study agreements, vendor specifications) /liliOversee study timelines, risks, and issue resolution, implementing mitigation plans where needed /liliEnsure inspection readiness through high-quality Trial Master File (TMF) management /liliSupport study budget tracking, including vendor invoice reconciliation /liliCollaborate with Clinical Supply to ensure timely provision of investigational product and study materials /liliContribute to investigator and study team meetings /liliDrive continuous improvement initiatives and operational excellence activities /li /ulpbr/ppbKey Requirements /b /pulliExperience managing global clinical studies across multiple regions /liliStrong vendor management experience, including oversight of CROs and external providers /liliProven ability to work cross-functionally with global stakeholders /liliExperience in risk management and escalation handling /liliSolid understanding of ICH GCP and clinical trial regulations /liliBackground in Clinical Operations within a sponsor or CRO environment /li /ulpbr/ppbWhat to do next: /b /ppIf this opportunity is of interest, please apply direct or share a copy of your CV to /ppbr/ppbNot what you’re looking for? /b /ppPlease contact Brook Bridges on for a confidential discussion about potential opportunities. /p
