IRT System Designer

Position: IRT System Designer / IRT Lead
Location: Remote – Preferred near Irvine, NJ or Lake County, IL
Duration: 12 Months
We are seeking an experienced IRT System Designer / IRT Lead to support clinical trial technology activities for a leading biopharmaceutical organization. The ideal candidate will have hands-on experience designing and managing IRT/RTSM/IWRS systems throughout the clinical study lifecycle.
Key Responsibilities:
Develop and maintain IRT requirements and system specification documentation based on clinical study protocols.
Lead IRT activities from initial requirements and system design through build, testing, UAT, go-live, amendments, and study closeout.
Develop IRT test scripts and lead/facilitate User Acceptance Testing (UAT).
Work closely with Clinical Operations, Data Management, Clinical Supply, vendors, and other cross-functional teams.
Required Qualifications:
3+ years of hands-on IRT/RTSM/IWRS experience; 2+ years may be considered for candidates coming from an IRT vendor.
Experience in biopharmaceutical/clinical research environments.
Strong experience writing IRT requirements and specification documentation.
Experience managing IRT systems from design/build through study closure.

Work arrangement
Yes