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Clinical scientist associate director (españa)

Amgen Inc. (Ir)
Publicada el 17 junio
Misión del puesto
Clinical Scientist Associate DirectorApplyremote type: Flex Commuter / Hybridlocations: Spain - Remotetime type: Full timeposted on: Posted Todayjob requisition id: R- ## Career CategoryClinical## ## Job DescriptionWhat you will doIn this role, the Clinical Scientist Associate Director supports the design, execution, and oversight of clinical trials and other late-phase global clinical studies. The role contributes to protocol development, study execution, medical monitoring support, and clinical data review, ensuring delivery of high-quality, decision-ready clinical data for regulatory submissions and scientific dissemination.* Support the design, start-up, and execution of general clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards.* Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments.* Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring.* Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.* Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable.* Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites.* Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.* Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.* Collaborate with clinical operations, biostatistics, safety, regulatory, and medica
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