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Clinical Systems IRT Manager

Company: Amgen
Location: Raleigh
Posted on: November 26, 2022

Job Description:

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 IRT Manager LiveWhat you will doLets do this. Lets 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 DescriptionThe 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 contactsDesign and lead all aspects of the development of study specific IRT technical documentsDocument issues and risks, and implement mitigation plans in partnership with study team and vendor PMIdentify and track study-related technical issues to resolutionClosely lead project-related timelines and associated activitiesWinWhat we expect of youWe are all different, yet we all use our outstanding contributions to serve patients.Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.We are all different, yet we all use our outstanding contributions to serve patients. The qualified professional we seek is a manager with these qualifications.Basic Qualifications:Doctorate DegreeORMaster's Degree and 3 years of interactive response technology (IRT) experienceORBachelor's Degree and 5 years of interactive response technology (IRT) experienceORAssociate degree and 10 years of interactive response technology (IRT) experienceORHigh school diploma/GED and 12 years of interactive response technology (IRT) experiencePreferred 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
  • 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 supervisionThriveSome of the vast rewards of working hereAs 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
    • 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 GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.Equal Opportunity StatementAmgen 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.Join UsIf 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, Puerto Rico and Canada 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.

Keywords: Amgen, Raleigh , Clinical Systems IRT Manager, Executive , Raleigh, North Carolina

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