Career Category ClinicalJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Local Trial Manager (LTM)LiveWhat you will doLet’s do this. Let’s change the world. We are expanding our clinical trials team and we are looking for skilled candidates for the Clinical Trial Manager position.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 implementation 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 implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study TeamCommunicate country status (including timelines and results) 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 deliver all study support staff and continually review country level risk mitigation to ensure study delivers to planWinWhat 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 experienceAdvanced knowledge of global clinical trial managementFluency in local language and business EnglishPreferred Requirements:BA/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 identifiable project management experience locallyBuild strong site relationships as well as other local relationships to ensure end to end study delivery is met.ThriveSome 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 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 benefits—with compensation and benefits rated above 4 stars (out of 5) on GlassdoorThis position is open to remote workers in RomaniaApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com.
