HOW MIGHT YOU DEFY IMAGINATION? 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, which is the key for us to becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together by researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Local Trial Manager (LTM) - Remote positionWhat 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. This is a remote position.
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 youWe 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 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.7 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 company.Experience 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 locally.Must be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met.Some of the vast rewards of working hereAs 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 journey.A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits.Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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