Global Clinical Trial Manager
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Nov 7, 2019
View more
- Discipline
- Clinical, Clinical Trials
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Amgen focuses on areas of high unmet medical need and leverages 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.
The Global Clinical Trial Manager is the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.
Responsibilities:
- Oversee the quality and scientific integrity of clinical operations for studies at a global level
- Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Lead the Clinical Study Team to drive effective decision making
- Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
- Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
- Management of study budget and timelines
- Management of vendors to the required standards
- 5% travel to support the execution of clinical studies
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.)
Experience of collaborating and leading cross-functional teams in a matrix environment
Experience of working internationally
Experience of managing complex projects across multiple countries and time zones
Experience of anticipating and resolving problems
Evidence of excellent interpersonal skills
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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