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eCOA Project Manager

2 months ago

Rahway, United States ICON Strategic Solutions Full time

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

RESPONSIBILITIES

  • Manage translation process and timelines with vendors
  • Kickoff eCOA development
  • Draft/finalize user requirement specifications
  • Execute UAT scripts / change requests
  • Establish Project Plan via Microsoft Project
  • Manage eCOA project schedule
  • Coordinate resolution & risk mitigation of all ePRO / eCOA-related issues and end-of-study vendor deliverables
  • Write / update standard operating procedures, develop a library of eCOA data capture and reporting standards, as needed
  • Provide support to the IVRS team, as needed
  • Work with Vendor PMs to maintain timelines and determine resources
  • Ensure sites/patients have device inventory
  • Manage new requirements / regulations across multiple countries
  • Support ongoing maintenance / database lock activities
  • Serve as eCOA Subject Matter Expert
  • Manage the decommissioning process with the eCOA vendor, at study close-out.

QUALIFICATIONS

Required:

  • 3 to 5+ years of experience working on clinical studies
  • electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient-Reported Outcome (ePRO) experience
  • 2+ years of project management and vendor management experience
  • Experience with eCOA / ePRO start-up/set-up, conduct, and closeout
  • Translation experience
  • Experience in executing UAT Scripts and/or Change Requests

Preferred:

  • InForm EDC experience
  • MS Project experience
  • Experience managing regulations and requirements across multiple countries
  • System and/or study design experience

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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