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 be the 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.
- Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
- Collaborates closely with SM-FSP Line Manager (FSP-LM) to ensure appropriate level of their staff oversight is deployed.
- Supports SM-FSP staff onboarding and training
- Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns
- Works with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
- Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
- Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
- Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.
- Involved in local and global site management and cross-functional stakeholder collaboration
- Actively participates in role forums including local and global functional and cross-functional initiatives
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.
We will ensure that individuals with disabilities are provided 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 accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.