Amgen Clinical Trial Oversight Manager in Denver, Colorado
HOW 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.
Clinical Trial Oversight Manager
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, escalation 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, and capacity management.
Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships.
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.
Doctorate degree OR
Master’s degree & 3 years of clinical experience OR
Bachelor’s degree & 5 years of clinical experience OR
Associate’s degree & 10 years of clinical experience OR
High school diploma / GED & 12 years of clinical experience
BA/BS/BSc in the sciences or RN
7 years’ work experience in life science or medically related field
4 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 GRDCA or QC department
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
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.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.