What are the responsibilities and job description for the eCOA Technical Project Manager position at Pharmaceutical Research Associates, Inc?
Overview
As a eCOA Technical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
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.
Qualifications
You are:
-
- 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
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.
