Job Description:

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.RESPONSIBILITIESManage translation process and timelines with vendorsKickoff eCOA developmentDraftfinalize user requirement specificationsExecute UAT scripts change requestsEstablish Project Plan via Microsoft ProjectManage eCOA project scheduleCoordinate resolution & risk mitigation of all ePRO eCOA-related issues and end-of-study vendor deliverablesWrite update standard operating procedures, develop a library of eCOA data capture and reporting standards, as neededProvide support to the IVRS team, as neededWork with Vendor PMs to maintain timelines and determine resourcesEnsure sitespatients have device inventoryManage new requirements regulations across multiple countriesSupport ongoing maintenance database lock activitiesServe as eCOA Subject Matter ExpertManage the decommissioning process with the eCOA vendor, at study close-out.QUALIFICATIONSRequired:3 to 5+ years of experience working on clinical studieselectronic Clinical Outcome Assessment (eCOA) andor electronic Patient-Reported Outcome (ePRO) experience2+ years of project management and vendor management experienceExperience with eCOA ePRO start-upset-up, conduct, and closeoutTranslation experienceExperience in executing UAT Scripts andor Change RequestsPreferred:InForm EDC experienceMS Project experienceExperience managing regulations and requirements across multiple countriesSystem andor study design experienceBenefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That's 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.