Senior Global Trial Manager

at  Amgen

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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

In this vital role you will be responsible for leading the successful delivery of our exciting and innovative clinical trial portfolio on time and within budget, 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, Rare Disease, Obesity and Observational Research.

• Leader of the cross-functional Clinical Study Team. Input operational expertise into the study design process.
• Lead and manage the operational strategy and execution of clinical trials from study design through to close out at a global level, ensuring the quality and scientific integrity of the trial in a Risk-Based Study Execution model
• Line Management of Global Trial Managers and Local Trial Managers
• 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
• Maintaining global business relationships cross-functionally and communicating global status of clinical trial to senior management as needed/required
• 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