Amgen Senior Manager Study Management / Program Management in Uxbridge, United Kingdom
Senior Manager Global Clinical Program Management / 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 successful Senior Manager candidate will join Global Clinical Program Management (GCPM) - GCPM plans and executes all operational aspects of clinical trials globally.
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 clinical trial programs globally.
You will support continuous improvement initiatives in GCPM and Global Development Operations (GDO).
Support GCPM Director in the following:
Global clinical program operational strategy, planning, risk assessment and mitigation, and overall execution
High-quality execution of clinical trials on time and within budget
Supports / Leads the Global Clinical Study Team for the allocated program(s)
Providing clinical operations leadership and expertise on the Evidence Generation Team (EGT) and in development of the Evidence Generation Plan (EGP)
Providing clinical operations leadership and expertise in EGP execution through the feasibility and study design process
Development and oversight of clinical program budgets including change control in collaboration with TA and Finance
Managing program-level operational issues and oversight of study team issue escalation
Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management
Representing GCPM on process improvement initiatives
Providing global or regional input to the GCPM TA departmental budget
Functional oversight of GCTM and RCTM, collaborates with People and Resources Manager (PRM) on performance management
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 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
Strategic Operational Planning
Matrix team leadership and ability to work in a matrix environment
Cross-Program data metric analysis and interpretation
Risk assessment / risk mitigation
Strong problem solving, decision making and influencing skills
Location: Uxbridge or Cambridge
Remuneration: Competitive salary & comprehensive benefits package including bonus scheme
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.