Senior Manager, Global Clinical Program Resources Management
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Feb 15, 2019
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Responsibilities:
Functional quality and business oversight of GCPM staff (Regular Full Time Staff and Functional Service Provider), including Global Clinical Trial Manager (GCTM), Regional Clinical Trial Manager (RCTM), Clinical Trial Specialist (CTS) and Study Management Associate (SMA)
Critical analysis of key functional performance indicators to mitigate potential risks
Effective and efficient issue management in a cross functional matrix
Line management, performance management, and mentoring of GCTM (RFT) staff
Ensure Global Clinical Program Management staff (RFT and FSP) adherence to operating standards and promoting standardization and best practice sharing to ensure compliance and operational efficiencies
Provide input into the learning management system and Role Based Curriculum makeup in GCPM
Oversee resourcing and allocation of GCTM, RCTM, and CTS staff
Lead GCPM on strategic staff-focused process improvement initiatives; Development standards authorship and/or review
Basic Qualifications:
Doctorate degree and 2 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting
OR
Master's degree and 6 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting
OR
Bachelor's degree and 8 years clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting
OR
Associate's degree and 10 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting
OR
High school diploma / GED and 12 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting
Preferred Qualifications:
BS/BA/BSc in the sciences or RN
9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
2+ years of direct managerial and/or leadership experience
Experience at, or oversight of, outside clinical research vendors (CRO's, central labs, imaging vendors, etc.)
Advanced knowledge of global clinical trial management, processes, and operations
Extensive knowledge of ICH/GCP regulations and guidelines
Project and Program management including oversight of study deliverables
Understanding of resource management and organizational capacity
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.
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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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