Career Category

Clinical

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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.

CLINICAL SYSTEMS & ANALYTICAL REPORTING (CSAR) MANAGER

LIVE

What you will do

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.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:

• 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

THRIVE

What you can expect of 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

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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.

We 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.

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