Amgen

Global Clinical Trial Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 21, 2020
Ref
R-95703
Required Education
High School or equivalent
Position Type
Full time
The Global Clinical Trial Manager is the primary point of contact to lead, manage and coordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.

We are building upon our solid oncology foundation and long-term dedication to patients by developing a whole new class of novel molecules across multiple therapeutic areas - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Responsible for delivering Amgen's Global Clinical Trial portfolio, in a fast-paced, highly innovative and collaborative environment. The Global Clinical Trial Manager (GCTM) role sits in the Global Clinical Program Management (GCPM) function, alongside our team of Regional Clinical Trial Managers (RCTM) responsible for Clinical trial delivery at the regional/country level.

Based in Thousand Oaks or San Francisco, Ca, the Global Clinical Trial Manager (GCTM) role leads the cross-functional Clinical Study Team responsible for successfully delivering our exciting and innovative clinical trial portfolio on time and on budget and in accordance with quality standards. In this highly rewarding role, no day will be the same and you will be at the forefront of innovative drug development.

Amgen's product pipeline covers many Therapeutic areas, including: Oncology, Hematology, Bone, Neuroscience, Inflammation, Cardiovascular and Observational Research.

5% travel to support the execution of clinical studies.

Responsibilities:
  • Lead the Clinical Study Team (CST). Manage the conduct of clinical trials from study design through to close out at global level, ensuring the quality and scientific integrity of the trial and drive informed decision making
  • Perform risk assessment and develop risk mitigation strategies to support study delivery
  • Timely management of issues
  • Oversight of and close collaboration with study team members as well as cross functional partners, through effective communication to ensure timely and on-budget execution of clinical trial deliverables
  • Effectively communicate Strategy and rationale for decisions to the CST
  • Ensure the conduct of studies in accordance with Regulatory Authorities, company SOPs and ICH-GCP guidelines including Trial Master File (TMF) Management, ensuring inspection readiness at all times
  • Manage of vendors to the required standards
  • Close Management of study budget and timelines


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of clinical experience

OR

Bachelor's degree and 5 years of clinical experience

OR

Associate's degree and 10 years of clinical experience

Or

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications:

Bachelor's degree

7+ 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 company

Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience acquired from working on clinical trials in a biotech, pharmaceutical or CRO company)

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 uses its 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.

Join Us

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.