IRT Manager, Clinical Supply Systems

IRT Manager, Clinical Supply Systems

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Be Doing:

• Establishes and maintains oversight of 3rd party IRT vendor.

• Works directly with study teams to gather requirements and ensure IRT system is developed in line with study protocol.

• Develops and manages system deployment timelines for IRT.

• Manages IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans.

• Coordinates user acceptance testing.

• Manages the deployment of IRT applications with internal teams and contract vendor.

• Provides guidance related to contracted vendors’ functionality, performance, and processes.

• Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)

• Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management.

• Confirm effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor.

• If required, attend Investigator Meetings or CRA Trainings to discuss system functionality and requirements

Your Profile:

• Minimum 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years with direct IRT system development and management experience.

• Experience with direct IRT system design/configuration/development for clinical trials required.

• Working knowledge of the IRT terminology and computer programming terms.

• Through understanding of clinical trial protocol and translation of key parameters related to IRT system development.

• Knowledge of ICH/GCP and regulatory guidelines/directives

• Understands current and future business trends as related to IRT development field.

• Demonstrates high level of leadership and negotiation skills and Mentoring/coaching skills.

• Ability to effectively multi-task and prioritize work in a matrix environment to support multiple stakeholder priorities

• Effective problem-solving skills.

• Ability to work autonomously, manage ambiguity and act decisively while balancing speed, quality, and risk.

• Excellent written and verbal communication and presentation skills in small and large group settings.

• Excellent Project management and organizational skills.

• Effective Computer skills, with competency in MS Office Suite.

• Cross functional and cross-cultural awareness.

Education:

• Bachelor’s Degree in IT, Computer Science preferred.

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At 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, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply