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Global study manager (alcobendas)

Alcobendas
Warman O'Brien
Publicada el 27 abril
Descripción

Pb Global Study Manager – Clinical Operations /b /pp Remote /pp FSP - Leading Global pharma /p p 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. /pp 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. /p pb Key Responsibilities /b /pulli Support end-to-end delivery of global clinical studies from set-up through to close-out and CSR /lili Coordinate cross-functional teams and external partners to ensure efficient study execution /lili Manage global vendors (including CROs) to ensure performance against timelines, cost, and quality /lili Contribute to study documentation (e.g. ICFs, study agreements, vendor specifications) /lili Oversee study timelines, risks, and issue resolution, implementing mitigation plans where needed /lili Ensure inspection readiness through high-quality Trial Master File (TMF) management /lili Support study budget tracking, including vendor invoice reconciliation /lili Collaborate with Clinical Supply to ensure timely provision of investigational product and study materials /lili Contribute to investigator and study team meetings /lili Drive continuous improvement initiatives and operational excellence activities /li /ul pb Key Requirements /b /pulli Experience managing global clinical studies across multiple regions /lili Strong vendor management experience, including oversight of CROs and external providers /lili Proven ability to work cross-functionally with general stakeholders /lili Experience in risk management and escalation handling /lili Solid understanding of ICH GCP and clinical trial regulations /lili Background in Clinical Operations within a sponsor or CRO environment /li /ul pb What to do next: /b /pp If this opportunity is of interest, please apply direct or share a copy of your CV to /p pb Not what you’re looking for? /b /pp Please contact Brook Bridges on for a confidential discussion about potential opportunities. /p

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