ICON Strategic Solutions ePRO Project Manager in Topeka, Kansas
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.
What will you be doing?
Provide end-to-end support to the ePRO startup, conduct, and closeout activities in any given trial
Activities include, but are not limited to:
Kickoff ePRO development
Draft/finalize user requirement specification o Participate in the UAT execution and manage ePRO project schedule
Coordinate resolution & risk mitigation of all ePRO related issues and end of study vendor deliverables
May write and/or update Standard Operating Procedures (SOPs), develop a library of ePRO data capture and reporting standards
May write and/or update job aides May provide support to the IVRS team in the capacity of IVRS coordinator, as needed
Establish Project Plan using Microsoft Project
Work with Vendor PMs to maintain timelines and determine resource
Participate and execute UAT scripts
Ensure sites and patients have device inventory
Submit change requests, as needed
Support database lock activities
Act as an ePRO Subject Matter Expert
What do you need to have?
- BA. or B.S. degree in Computer Science, Biology, or a related discipline
Minimum of 5 years' experience in Clinical Data Management (CDM) as a Lead Clinical Data Coordinator with solid experience in study startup activities for EDC Form/ePRO
Past ePRO startup, conduct, and closeout experience is a plus
Understanding of clinical trials protocols and therapy areas Strong communication and project management skills Attention to detail
Familiarity working with Microsoft Project
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.