Clinical Systems IRT Manager
AmgenUs - california - los angelesUpdate time: April 8,2022
Job Description

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 IRT MANAGER

LIVE

What you will do

In this global vital role, you will provide technical oversight to ensure that IRT solutions is carried out to the study protocol, industry regulations, best practices as well as company policies, procedures, and guidelines

You will ensure to achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of Global Development Operations (GDO).

Key responsibilities include:

  • Lead and facilitate system requirements, bring together clinical study teams and IRT supplier contacts
  • Design and lead all aspects of the development of study specific IRT technical documents
  • Document issues and risks, and implement mitigation plans in partnership with study team and vendor PM
  • Identify and track study-related technical issues to resolution
  • Closely lead project-related timelines and associated activities

Be part of our team

You would be joining Amgen’s IRT team, part of the Clinical Systems & Analytical Reporting (CSAR) organization.  The IRT team is based mostly in the USA with line management support in the USA and UK; however, day-to-day communications in this position will be had with the full Amgen Clinical Study Teams which have staff located across the globe.  You will work in these international, cross-functional teams developing and supporting IRT solutions for our clinical pipeline.  You will have regular interactions with external IRT vendors responsible for the programming and hosting of our IRT systems.

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 in life science, computer science, business or related subject area
  • Experience of interactive response technology (IRT)
  • Proven experience in clinical operations, clinical supply chain or clinical systems management
  • Experience implementing clinical systems such as IRT eCOA
  • Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution.
  • Detail-oriented and able to lead many projects simultaneously.
  • Excellent documentation and communication skills
  • Vendor management experience coupled with facilitation skills
  • Excellent time management and organization skills in a fast-paced environment
  • Sound problem resolution, judgment, and decision-making abilities

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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • 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 or from our offices in UK, US or Netherlands.

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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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,

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