Amgen Inc.

Clinical Trial Oversight Manager

Posted on: 5 Mar 2021

Denver, CO

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Live

What you will do

Lets do this. Lets 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.

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
* Masters degree & 3 years of clinical experience OR
* Bachelors degree & 5 years of clinical experience OR
* Associates degree & 10 years of clinical experience OR
* High school diploma / GED & 12 years of clinical experience

Preferred Qualifications:

* 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

Thrive

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

Amgen Inc.

Oakland, CA

Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of oncology/hematology, cardiovascular, inflammation, bone health, and neuroscience. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta, a pegylated protein to treat cancer patients; Prolia to treat postmenopausal women with osteoporosis; Aranesp to treat anemia; Xgeva for skeletal-related events prevention; Sensipar/Mimpara products to treat sHPT in chronic kidney disease; and EPOGEN to treat a lower-than-normal number of red blood cells.

It also markets other products in various markets, including Kyprolis, Nplate, Vectibix, Repatha, NEUPOGEN, Parsabiv, Blincyto, Aimovig, Imlygic, Corlanor, Kanjintitm, and Amgevitatm. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. The company has collaborative agreements with Novartis; UCB; Bayer HealthCare Pharmaceuticals Inc.; and DaVita Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.