Local Trial Manager
hace 2 meses
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 achievetogether—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 POSITION LIVEWhat you will doLet'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 deliveryPlanning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study TeamCommunicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparencyProvides 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 studySupport internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor managementAssign and lead all aspects of deliverables of study support staff and continually review country level risk mitigation to ensure study delivers to planWIN 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 RequirementsDoctorate 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 experienceAdvanced knowledge of global clinical trial managementFluency in Spanish language and business EnglishPreferred RequirementsBA/BS/BScMinimum 2-3 years' experience of leading local/regional or global teamsMinimum 2-3 years' clinical trial project management experience7 years' work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO companyExperience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)Must be a local/country expert with proven project management experience locallyMust be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is metTHRIVESome of the vast rewards of working here As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefitsAmgen is committed to equal treatment, diversity and the inclusion of employees with disabilities, and is open to all. If you have a disability, do not hesitate to inform your Human Resources contact of any adaptations or tools required for the recruitment process to run smoothly. If you have any specific questions relating to your disability, please do not hesitate to ask them in confidentiality.
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