Clinical Systems Project Manager - IRT

Overview

As a IRT 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:

• Responsible for IRT implementation project management, IRT requirements and design, user acceptance testing, and maintenance
• May contribute to mentoring Clinical Supply Systems Specialists
• Responsible for facilitation of IRT support, data changes, and working with Clinical Operations and Monitoring to achieve their goals
• Responsible for UAT test case creation, oversee and facilitate signatures on documentation, and risk and impact assessment creation, etc.
• Adheres to processes and ensure compliance to relevant SOPs
• Responsible for administration and uploading documentation to appropriate eTMF
• Collaborates cross-functionally to schedule projects, end-user training, meetings, and discussions
• Deliver exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management under the directive of the Senior Manager
• Serve as IRT Subject Matter Expert

Qualifications

You are:

• At least three to six years of clinical supply systems experience
• Bachelor’s degree in a science-based subject (advanced degree preferred)
• Prior Product Ownership Experience (strongly preferred)
• Prior demonstration of innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment
• Understanding of Cold Chain distribution and the effect on IRT
• IRT Subject Matter Expertise
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors
• Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol 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, inclusion & belonging are fundamental to our culture and values. 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, 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 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.