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About the Role
Amgen is seeking a Senior Manager of Local Study Operations to lead and develop a team of Local Study Operations Managers (LSOMs). This role is crucial for ensuring the successful delivery of the country’s clinical trial portfolio from feasibility through study close-out, driving operational excellence, and supporting Amgen’s clinical development strategy.
Responsibilities
- Lead and develop a team of Local Study Operations Managers (LSOMs).
- Ensure the successful delivery of the country’s clinical trial portfolio.
- Drive operational excellence by overseeing study execution, portfolio performance, resource planning, and quality.
- Foster collaboration across global and local stakeholders.
- Oversee the delivery of the country study portfolio, ensuring studies are executed on time, within scope and budget, and in line with quality and regulatory requirements.
- Monitor portfolio performance, identify risks and quality trends, and lead issue escalation, mitigation, and resolution.
- Manage LSOM and supplier performance.
- Drive resource planning and workload allocation across FTE and FSP teams.
- Partner with the Country-Hub Head and cross-functional stakeholders to align study strategy and ensure successful portfolio execution.
- Foster operational excellence through continuous improvement, knowledge sharing, adoption of best practices, and digital innovation.
Requirements
- Degree educated with significant clinical operations experience.
- Experience leading people, teams, projects, or programs within a clinical research environment.
- Proven experience delivering clinical trials within a biotech, pharmaceutical, or CRO setting.
- Experience managing clinical operations across the UK, including strong understanding of local regulatory requirements around global clinical trials.
- Experience overseeing clinical research suppliers (e.g., CROs, central labs, imaging vendors).
- Strong understanding of global clinical trial operations and local regulatory requirements.
- Ability to manage resources, budgets, timelines, and performance metrics.
- Excellent stakeholder management, communication, and cross-functional collaboration skills.
- Continuous improvement mindset with the ability to drive operational excellence and implement best practices.
Skills
- Clinical operations
- Team leadership
- Project management
- Program management
- Clinical trial delivery
- Biotech/pharmaceutical/CRO operations
- UK clinical operations
- Local regulatory requirements
- Supplier management
- Global clinical trial operations
- Resource management
- Budget management
- Timeline management
- Performance metrics
- Stakeholder management
- Communication
- Cross-functional collaboration
- Continuous improvement
- Operational excellence
- Best practices implementation
Location
- Cambridge
- Uxbridge
Work Type
- Flexible from home
- Regular office work
Experience Level
- Senior Manager
- Experienced professional
Education Level
- Degree educated
Benefits
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
About the Company
- Amgen's shared mission is to serve patients, driving all that they do.
- They are one of the world’s leading biotechnology companies.
- They are global collaborators researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.
Equal Opportunity
- Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- They will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
- Please contact us to request an accommodation.