Amgen Global Clinical Trial Manager (multiple positions available) in Uxbridge, United Kingdom

Global Clinical Trial Manager (multiple positions available)

Function: Global Clinical Program Management

About Amgen:

Amgen is one of the world's leading independent biotechnology companies, with global revenues in excess of $20 billion and over 20,000 employees. For more than 30 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

The 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 within the Global Development Operations organization in the Global Clinical Program Management function, alongside our team of Regional Clinical Trial Managers responsible for Clinical trial delivery at the regional/country level.

The Global Clinical Trial Manager reports into the Program and Resource Management senior manager role with project oversight performed by the Clinical Program Manager role.

The Role:

Based in the Cambridge or Uxbridge office, the Global Clinical Trial Manager (GCTM) role is the lead of the cross-functional Clinical Study Team responsible for successfully delivering our exciting and innovative clinical trial portfolio on time and on budget. You will achieve this through close collaboration with study team members, driving effective decisions and proactively identifying opportunities as well as risks and their mitigations. In this highly rewarding role, no day will be the same. Amgen's product pipeline covers many Therapeutic areas, including: Oncology, Haematology, Bone, Neuroscience, Inflammation, Cardiovascular and Observational Research.

Summary of key responsibilities:

  • Leader of the 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 Collaboration with cross functional stakeholders, through effective communication and proactive risk identification, 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 Authority, company SOPs and ICH-GCP guidelines including Trial Master File (TMF) Management, ensuring inspection readiness at all times.

  • 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.

Location: Amgen UK Office Based (Uxbridge or Cambridge)

Close Date: All applications to be submitted by COB Friday 3rd August, 2018

Basic Qualifications

  • BA/BS/BSc or RN

  • Regional 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)

Preferred Qualifications

  • Global clinical project management experience

  • 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)

  • Knowledge of time, cost and quality metrics, Key performance indicators (KPIs)

Key Competencies for the role:

  • Ability to lead and work effectively in a global team/matrix environment on multiple projects

  • Analyze data to identify trends and patterns to support mitigation activities/actions

  • Critical thinking and horizon scanning

  • Problem solving

  • Informed decision making

  • Relationship Management and influencing skills

  • Organizational and planning skills

  • Strong IT skills to manage internal systems and reporting