15 oct
|
Amgen
|
Canarias
Career Category Clinical Job Description What you will do In 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 global 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 general 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 medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies. * Contribute to clinical study reports, regul
📌 Clinical Scientist Associate Director (Canarias)
🏢 Amgen
📍 Canarias