ePRO Project Manager

As a ePRO Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Manage translation process and timelines with vendors
• Kickoff ePRO development
• Draft/finalize user requirement specifications
• Execute UAT scripts / change requests
• Establish Project Plan via Microsoft Project
• Manage ePRO 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 ePRO 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 ePRO Subject Matter Expert
• Manage the decommissioning process with the eCOA vendor, at study close-out.

You are:

Required Experience:

• 3 to 5+ years working on clinical studies 
• electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient-Reported Outcome (ePRO) experience
• 2 to 3+ years of project management and vendor management
• Study protocol analysis experience, including requirements extraction COA builds and creation / implementation of study design plans
• Translation knowledge & experience, including experience working with translation teams/vendors
• Execution of UAT Scripts and/or Change Requests
• Solid study start-up experience, including having led cross-functional kickoff meetings for EDC, ePRO and/or eCOA activities
• Study close-out experience, including: international device shipping (returns), archiving, risk mitigation, and management of decommissioning activities with eCOA vendor 

Preferred Experience:

• InForm EDC
• MS Project
• Global management of regulations and requirements 

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.