Amgen Global Clinical Trial Manager - 2 Positions Available in Uxbridge, United Kingdom
HOW MIGHT YOU DEFY IMAGINATION?
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.
Global Clinical Trial Manager x 2
What you will do
In this vital role you will be responsible for successfully delivering our exciting and innovative clinical trial portfolio on time and on budget and in accordance with quality standards. 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, Haematology, Bone, Neuroscience, Inflammation, Cardiovascular and Observational Research.
Leader of the cross-functional Clinical Study Team. 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 in a Risk-Based Study Execution model
Oversight of and close collaboration with study team members as well as cross functional stakeholders, through effective communication and proactive identification of opportunities as well as risks, management and mitigation to ensure timely and on-budget execution of clinical trial deliverables
Leading the Clinical Study Team to drive effective decision making.
Ensuring 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.
Perform risk assessment and develop risk mitigation strategies to support study delivery
Effective management of vendors to the required standards
Lead/support global process development and improvement activities
Travel as required to support the execution of clinical studies as required
Be part of our team
You would be joining a team where we are building upon our solid oncology foundation and long-term commitment 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.
The team are 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 responsible for Clinical trial delivery at the regional/country level.
The GCTM reports into the Clinical Program Manager role.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
BA/BS/BSc or RN
Global clinical project management experience
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 obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
Knowledge of time, cost and quality metrics, Key performance indicators (KPIs)
Extensive clinical research experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
Experience in Oncology is preferred but not essential
Experience in innovative trial design, adaptive trial design is preferred but not essential
What you can expect of us
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.
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
Some flexible home working is available
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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.