Amgen Senior Manager Study Management / Program Management in Uxbridge, United Kingdom

Title: Senior Manager Global Clinical Program Management, Observational Research / Senior Study Manager

If you are interested working on exciting portfolio of complex studies within fast paced global environment this role will keep you challenged whilst focussing on our Mission: To serve patients.

The Team:

The successful Senior Manager candidate will join Global Clinical Program Management (GCPM) - GCPM plans and executes all operational aspects of clinical trials globally.

The Role:

As a Senior Manager Global Clinical Program Management, you will coordinate and oversee the operational strategy, planning, risk assessment and mitigation, and overall execution of observational research (OR) studies executed by GCPM OR.

You will support continuous improvement initiatives in GCPM and Global Development Operations (GDO).

Responsibilities

Support GCPM Director in the following:

  • Global clinical program operational strategy, planning, risk assessment and mitigation, and overall execution

  • High-quality execution of OR on time and within budget

  • Development and oversight of OR budgets including change control in collaboration with TA, CfOR and Finance

  • Managing operational issues and oversight of study team issue escalation

  • Maintaining global business relationships cross-functionally and communicating global study status to senior management

  • Representing GCPM OR on process improvement initiatives

  • Functional oversight of GCTM and RCTM, collaborates with People and Resource Manager (PRM) on performance management

  • Oversight of vendor performance, scope of works and budgets

  • Lead planning for regulatory agency inspection readiness activities and ensure execution of plans

  • Contribute to development and maintenance of policies, SOPs and associated documents

Basic Qualifications and proven experience required:

  • Degree educated in relevant subject

  • In-depth experience working in life sciences or medically related field, including specialist biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)

  • Previous management experience of direct reports

  • Experience at or oversight of outside clinical research vendors (CRO's, central labs, imaging vendors, etc)

  • Advance knowledge of global trial management

  • Clinical trial processes and operations

  • Knowledge of ICH/GCP regulations and guidelines

  • Project and program management including oversight of study deliverable, budgets and timelines

  • Time, cost and quality metrics

  • Relevant therapeutic knowledge

Preferred experience

  • Experience conducting and/or overseeing observational research execution in an industry setting

  • Previous management experience of direct reports

  • Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc)

Location: Uxbridge or Cambridge

Remuneration: Competitive salary & comprehensive benefits package including bonus scheme

The company:

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.

Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 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.