Clinical Systems & Analytical Reporting Manager

In this vital role you will be responsible for assisting with technology implementation and study deliverables tasks to consistently deliver outstanding results in quality, and services of all supported clinical systems and reporting.

• Lead and co-ordinate the definition of study design and standards in clinical trial databases and systems
• Manage clinical trial platform technologies and support decision-making by acting as a data scientist, bringing awareness to patterns and analytical insight
• Manage and operational oversight of Global Development Operations (GDO) systems, platforms and tools (eg, EDC, IRT, CTMS) to ensure compliance to regulatory bodies
• Ensure quality and timely operational delivery of systems activities supporting study or product level delivery, eg, data standards/Global Library management
• Provide technical and business process input on new and emerging technologies/vendors for clinical trial execution
• Develop, review and implement processes, policies, SOPs and associated documents affecting GDO
• Promote the continuous improvement of CSAR and the wider development organization through information sharing, training, mentoring and education
• Promote and be an advocate for GDO internally and externally
Be part of our team You would be joining a global team dedicated to accelerate clinical programs using innovative technologies, processes, programming standards, and growth of systems and analytics capabilities.


• Degree educated
• Knowledge in data management / programming in the Pharmaceutical or Biotech fields
• Previous project management and planning experience
• Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, IRT vendors, etc.)
• Knowledge of Good Clinical Practices (GCP) and familiarity with regulatory requirements
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
• Proficient in organizational applications and tools (e.g., Spotfire, MS Office)
• Excellent written and verbal communication
  
  If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
  
  As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits