Local Trial Manager

hace 1 mes


Madrid, España Amgen Sa A tiempo completo

.If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us as:LOCAL TRIAL MANAGER - REMOTE POSITIONWhat you will do Let's do this. Let's change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR/Archival) at a country level in accordance with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials at a local/country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget execution of clinical trial results within the local country.Key Activities: Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery.Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team.Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency.Provides country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study.Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.G., vendor management.Assign and lead all aspects of deliverables of study support staff and continually review country level risk mitigation to ensure study delivers to plan.What we expect of you We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Trial Manager with these qualifications.Minimum Requirements Doctorate degree ORMaster's degree & 3 years of directly related experience ORBachelor's degree & 5 years of directly related experience ORAssociate's degree & 10 years of directly related experience ORHigh school diploma / GED & 12 years of directly related experience.Advanced knowledge of global clinical trial management.Fluency in Spanish language and business English.Preferred Requirements BA/BS/BSc.Minimum 2-3 years' experience of leading local/regional or global teams.Minimum 2-3 years' clinical trial project management experience



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