Clinical Systems IRT Manager

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Systems IRT - Manager

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).

The Clinical Systems & Analytical Reporting (CSAR) IRT Manager will work with a cross-functional team of internal stakeholders 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, best practices 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic 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 8 years of interactive response technology (IRT) experience OR

• High school diploma/GED and 10 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 trial execution.

• 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

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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 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.