Amgen Global Clinical Trial Manager (multiple positions available) in Uxbridge, United Kingdom
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Find out more about the Amgen science here: https://www.amgenscience.com/
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.
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 (RCTM) responsible for Clinical trial delivery at the regional/country level.
The GCTM reports into the Program and Resource Management Senior Manager role with project oversight performed by the Clinical Program Manager 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 and in accordance with quality standards. . In this highly rewarding role, 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.
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 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
Location: Amgen UK Office Based (Uxbridge or Cambridge with some flexible working available)
Remuneration: Competitive salary and benefits package
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 innovative trial design, adaptive trial design
Experience in Oncology is preferred but not essential
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
Informed decision making
Relationship Management and influencing skills
Good prioritisation and time management
Organizational and planning skills
Strong IT skills to manage internal systems and reporting