Clinical Trials Oversight Manager

Career Category Clinical Development Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role. Clinical Trial Oversight Manager Live What you will do Let’s do this. Let’s change the world. In this vital role you will Single point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, including the identification, partner concern and resolution of quality and delivery issues. Provides GSO SM functional area expertise and actively collaborates in a dynamic cross-functional environment Oversight of the site contracting process. Line Manager to SCBAs. Performs oversight activities of FSP staff including CTA and CRA performance, delivery and quality metrics (KPIs, report(s) metric analysis/review) in collaboration with FSP-LM. Collaborates closely with FSP Line Manager (FSP-LM) to ensure appropriate level of oversight deployed. Supports CTA and CRA onboarding and training. Supervises staff involved in local site contracting and budget management, insurance, and payment process. Point of escalation to support resolution of issues (eg. quality, staff turnover). Works with FSP vendor(s) to ensure timely and appropriate planning, resource. Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The mature professional we seek is a team-player with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree & 3 years of clinical experience OR Bachelor’s degree & 5 years of clinical experience OR Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) Preferred Qualifications: BA/BS/BSc in the sciences or RN 7 years’ work experience in life science or medically related field 5 years’ experience working in clinical site management (working on clinical trials at a biotech, pharmaceutical or CRO company) Solid understanding of the Functional Service Provider operational model Knowledge of or work experience with a biopharmaceutical QC department Resource, planning, capacity management and process analysis skills Experience in monitoring contracting & invoicing processes Thrive Some of the vast rewards of working here As we work to develop treatments that look after others, we also work 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen