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:

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.

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