Clinical Risk Management Manager
2 months ago
If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
CLINICAL RISK MANAGEMENT MANAGER
LIVE
What you will do
Let's do this. Let's change the world. In this vital role you will coordinate and support cross-functional teams with the execution of high-quality risk management for all clinical trials and programs managed by Global Development Operations (GDO), covering early, late and observational programs.
- Supporting the Clinical Study Team (CST) to drive effective decision making for risk management
- Ensuring risk management implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
- Co-ordinating the Clinical Trial Risk Assessment and Categorization Tool (CT-RACT) completion and updates (by the CST) throughout the lifecycle of the clinical study
- Input to the development of the study protocol and functional plans
BE PART OF OUR TEAM
You would be joining the Clinical Trial Risk Management Team based remotely across the UK and USA. The team is part of Operational Quality in the Clinical Program Operations organisation. We work to underpin the protection of patients and study data by supporting cross-functional global Clinical Study Teams with robust risk management of their study's critical risks. This is an expanding team embedding a new capability with continuous improvement and innovation.
WIN
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Clinical Risk Manager with these qualifications.
- Degree Educated
- Experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
- Advanced knowledge of global clinical trial management
- Proven experience of, or oversight of, outside clinical research vendors (CROs, central labs, imaging vendors, etc.)
- Strong analytical, critical-thinking and decision-making abilities
- Excellent verbal and written communication skills, including strong business writing abilities and active listening
- Experience as a Risk Manager, preferred
THRIVE
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- 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
LOCATION Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Candidates who do not live within a commutable distance have the opportunity to work fully remotely within the United Kingdom.
APPLY NOW
Objects in your future are closer than they appear. Join us.
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 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.
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