ICON Strategic Solutions eCOA Analyst in Boston, Massachusetts
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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.
TheeCOA Analystwill mainly support activities related to setting up PRO questionnaires, diaries, and other COA on technologies supported by the Digital Health CoE.
EBIS Digital Health CoE ensures various technologies used within clinical studies are study-specific (e.g., relevant for study design, country, language), validated, and compliant.
Technologies / Services may include eCOA, pCOA e-Informed Consent, iSTEP, and apps for ePRO collection.
The eCOA Analyst will be required to have a good knowledge of clinical research and the use of technologies within clinical trials.
Provide support to Digital Health Managers/Specialists regarding UAT scripts, review, and testing.
Assist in research and information gathering regarding copyright requirements, licensing and user agreement requirements for instruments, such as COAs and cognitive batteries
Establish language availability and translations methodology for trial participant instruments, such as questionnaires and diaries
Manage Best Practices documents for Copyright, Translations and Printing, and assist with the development of other standardization documents and procedures
Assist with inspection readiness activities, as needed
Assist in Conducting Lessons Learned sessions following the completion of start-up activities, and, as necessary, throughout other phases of the clinical development process
Assist team with vTMF activities across EBIS Digital Health CoE
Monitor key performance indicators (KPIs) for services provided by suppliers and track metrics
Effectively support the study team in close-out/deactivation of systems
Maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure the Digital Health CoE's processes are at the ‘best practice’ level of performance.
Bachelor’s degree (University degree) or equivalent, or 2+ years of relevant experience.
Minimum of 2+ years working in a pharmaceutical company and/or a Contract Research Organization (CRO), or other equivalent exposure to clinical research.
Expertise working with clinical technologies, such as eCOA/COA, ePRO, Imaging, ECG, Direct to Patient, Telemedicine, Actigraphy, etc
Strong project management skills.
Strong listening, oral and written communication skills.
The ability to facilitate interactive sessions with the business and functional personnel.
Ability to track, monitor and communicate relevant issues and risks and suggest alternative approaches/recommendations.
Ability to work independently and to involve management when needed. Benefits 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.
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Posted Date 1 week ago (11/14/2022 8:55 AM)
Location : Location US-Remote
ICON Strategic Solutions
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