Clinical Systems IRT Manager

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree.

How will you use that achievement to reach your goals?

Do more with the knowledge youve worked hard to acquire and the passion you already have.

At Amgen, our shared missionto serve patientsdrives all that we do.

It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide.

Become the professional you are meant to be in this meaningful role.

Clinical Systems & Analytical Reporting (CSAR) IRT Manager Live What you will do Lets do this.

Lets change the world.

In this vital role the Clinical Systems & Analytical Reporting (CSAR) IRT Manager will work with a cross-functional team of internal customers including but not limited to Clinical study teams, Data Management functions and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial.

The CSAR IRT Manager will provide technical oversight to ensure that IRT solutions is carried out to the study protocol, industry regulations, standard methodologies as well as company policies, procedures, and guidelines.

Lead and facilitate system requirements, bring together clinical study teams and IRT supplier contacts Design and own 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 supervise study-related technical issues to resolution Closely lead project-related timelines and associated activities Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.

The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications: Doctorate Degree or a Master’s Degree and 3 years of interactive response technology (IRT) experience Bachelor’s Degree and 5 years of interactive response technology (IRT) experience Associate degree and 10 years of interactive response technology (IRT) experience High school diploma/GED and 12 years of interactive response technology (IRT) experience Preferred Qualifications: 10 years of Interactive Response Technology experience Bachelors Degree in life science, computer science, engineering, business, or related subject area 4 years of experience in clinical operations, clinical supply chain or clinical systems management Experience implementing clinical systems, such as IRT and eCOA Solid understanding of Good Clinical Practices and FDA regulations governing clinical trial execution.

Detailed and able to lead many projects simultaneously.

Excellent documentation and communication skills Meeting management and facilitation skills Vendor management experience Excellent time management and organization skills in a fast-paced environment Sound problem resolution, judgment, and decision-making abilities Work well in a team-based environment with minimal direction Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination Objects in your future are closer than they appear.

Join us.

Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics.

Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.

Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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 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 accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment.

In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance.

Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.