Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Clinical Systems IRT Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will 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).

Job Description

The Clinical Systems & Analytical Reporting (CSAR) IRT Manager will work with a cross-functional team of internal collaborators 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 processes as well as company policies, procedures, and guidelines.

Responsibilities:

• 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a manager with these qualifications.

Basic Qualifications:

Doctorate Degree

Or

Master's Degree and 2 years of interactive response technology (IRT) experience

Or

Bachelor's Degree and 4 years of interactive response technology (IRT) experience

Or

Associate degree and 10 years of interactive response technology (IRT) experience

Or

High school diploma/GED and 12 years of interactive response technology (IRT) experience

Preferred Qualifications:

• 10+ years of Interactive Response Technology experience
• Bachelor’s 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
• Working knowledge of Good Clinical Practices and FDA regulations governing clinical trials.
• Detail-oriented 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 supervision

Thrive

What you can expect of us

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.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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 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.

Salary Range