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IRT and eCOA Governance Lead- Remote

Employer
Amgen
Location
Bethlehem, PA
Start date
Sep 30, 2022
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Job Details

Role Title

Amgen System Study Services is looking for an experienced IRT and eCOA Governance Lead Sr Manager

Our Team:

Amgen IRT and eCOA Governance Lead works with internal stakeholders and IRT and eCOA vendors to support the IRT and eCOA system delivery, maintenance and provide subject matter expertise for projects related to the IRT and eCOA Team with a focus on delivery oversight from a Quality and Compliance perspective.

IRT and eCOA Governance Lead role overview:

The Interactive Response Technology (IRT) and electronic Clinical Outcomes Assessments (eCOA) Governance Lead Sr. Manager will work in a team-based environment and a cross functional team of Clinical representatives to support the Governance of our vendors within the space and be responsible for reviewing study and program level issues that require escalation. Provide input to monitoring visit agendas and technical expertise related to IRT and eCOA development. Mentoring and training staff in the IRT and eCOA roles on Governance and Oversight related issues and procedures. This role will work closely with the IRT and eCOA Operations lead to ensure all issues are appropriately documented in our issue tracking system and escalated as appropriate to other Governance functions when required. They will be the responsible for creating agendas, leading FMT meetings and documenting minutes and actions. The individual within this role will provide technical oversight to ensure that the study specific IRT or eCOA systems adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines. This role will also be responsible for oversight of our TMF and compliance to our quality and timeliness goals.

Responsibilities:

  • Accountable for ensuring quality delivery from our vendors and escalations
  • Chair of the FMT meetings with IRT and eCOA vendors and internal stakeholders
  • Establish and drive a high level of oversight for delivery in the IRT and eCOA Governance function
  • Participate in the Qualification of new vendors and technology as required
  • Leverage deep understanding of business processes to search for new methodologies which will drive efficiency, quality, and compliance
  • Identify and track study-related technical issues to resolution
  • Provide a supportive framework for continuous process and quality improvements
Qualifications and required experience:

Basic Qualifications:

Doctorate degree and 2 years of IRT and/or eCOA clinical experience

OR

Masters degree and 6 years of IRT and/or eCOA clinical experience

OR

Bachelors degree and 8 years of IRT and/or eCOA clinical experience

OR

Associates degree and 10 years of IRT and/or eCOA clinical experience

OR

High school diploma / GED and 12 years of IRT and/or eCOA clinical experience

Preferred Qualifications:

  • Bachelors Degree in life science, computer science, engineering, business or related discipline
  • 5+ years work experience in life sciences or a medical related field
  • Experience implementing clinical systems, such as eCOA, DHT, IVRS or other related technology in the pharmaceutical/biotechnology industry
  • Strong leadership skills demonstrating the ability to champion new ideas and challenge the conventional mindset and status quo
  • Exemplary customer service skills, as demonstrated in being able to pivot quickly to emerging or changing business requirements while leveraging business relationships to maximize product delivery
  • Knowledgeable in Good Clinical Practices, and FDA regulations related to SDLC
  • Project management and technical expertise, attention to detail, and excellent documentation and communication skills
  • Previous vendor management experience
  • Excellent time management and organization skills
  • Have sound problem resolution, judgment, and decision-making abilities
  • Be able to work well in a team-based environment with minimal supervision

Location: US

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme

About our company:

Amgen is one of the worlds largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.


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, 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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