Global Clinical Trial Manager

1 week ago

London, Greater London, United Kingdom Amgen SA Full time

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

LIVE

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.

  • 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 cross-function 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 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/Local Team Manager responsible for Clinical trial delivery at the regional/country level.

The GCTM reports into the Clinical Program Manager role.

WIN

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 is preferred however significant regional project management experience with exposure to some global tasks will be considered
  • Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
  • Global cross-functional leadership experience (preferred)
  • Line Management experience preferred but not essential
  • 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

THRIVE

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
  • Flexible working from home and remote options available within the UK

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.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.

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