Amgen Manager, Clinical Data Analytics in Uxbridge, United Kingdom

Title: Manager, Clinical Data Analytics / Clinical Application & Analytical Services Manager

The Team:

Clinical Systems Analytical Reporting (CSAR)- Analytics team within Global Development Operations drives critical and analytical, the team enables decision making by providing insightful analytics and business intellect formed through strong business partnerships and data intelligence.

The Role:

The Clinical App & Analytical Services Manager's primary focus will be to advance analytical reporting and services across Global Development Operations and foster business process expertise to provide insightful, data correlations and data intelligence, which will drive forward decision-making and monitor expected performance.

Responsibilities

  • Effectively partner with cross-functional team members, by guiding discussions on optimized methods for data collection, standardization, governance, and reporting in order to develop innovative, analytical solutions

  • Drive forward improvement projects which interface with Informatics and Analytics across development through active vendor oversight, the Analytics Operations Lead will be responsible for direct management and oversight of vendor services, ensuring quality and timeliness of vendor product delivery.

  • Provide insights, business intelligence, and management analytics for effective decision making in alignment with Global Networks and Continuous Improvement strategies

  • Leverage BPO contacts to champion reporting needs which align to business practices and seek opportunities to drive change

  • Support study team activities, operating review meetings, and management requests through the delivery of information to support performance progress

  • Prioritize business needs and manage expectations for deliverables and exude transparency to development plans

  • Grow knowledge for how business processes, systems and reports work together to support business decisions

  • Streamline efficient and effective methods for business process automation

  • Perform quality oversight including quality gate controls validating deployment releases

  • Plan, track, and ensure execution of products and services via Functions Service Providers (FSPs)

  • Provide direct and routine timeline management while providing regular updates back to the requester(s)

  • Collaborate with interfacing technical teams including Data Management Systems and Information Systems to identify report(s) dependencies, engineer design solutions, and orchestrate deliverables towards a common goal

  • Prepare anticipated refreshed metric cycles, while analyzing data variances and trending to explain delta's or deviations in partnership with business owner

Basic Qualifications

  • Relevant Degree and proven professional clinical experience

Proven experience within:

  • Solid work experience in life sciences or medically related field, including biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)

  • Strong understanding of the concepts of clinical research and drug development

  • Strong understanding and experience in the use of performance management techniques, measurement and visualization- especially in Spotfire

  • Strong understanding of principals of customer service as it applies to internal and external customers

  • Advanced computer and system operation skills

  • Continuous improvement principles and their application e.g., Six Sigma

  • Understanding of project management software

  • Good organizational and planning skills

  • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

  • Familiar with other Data Management systems (IVR, EDC, CTMS etc.)

Location:

Primary - Uxbridge or Cambridge in the UK

Secondary - US/ Canada Amgen Locations

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme

The company:

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.