IRT Systems Designer

The Fountain Group is a national staffing firm and we are currently seeking an IRT System Designer for a prominent client of ours. This position is REMOTE. Details for the position are as follows: IRT System Designer / IRT LeadLocation: Remote; preference for candidates located near client offices in Irvine, CA; New Jersey; or Lake County, ILContract Length: 12 monthsPay: $42 - $46/hour depending on previous experience Schedule: Monday-Friday, approximately 8:00 AM-5:00 PM; PST, CST, or EST business hours Position OverviewWe are seeking an experienced IRT System Designer / IRT Lead to support clinical trial activities within a biopharmaceutical environment. This individual will serve as the primary IRT representative for assigned clinical studies and will be responsible for leading IRT activities throughout the study lifecycle, from initial system design and build through testing, implementation, maintenance, and study closure. The ideal candidate will have hands-on experience with Interactive Response Technology (IRT), RTSM, IWRS, or IxRS systems, with particular expertise in drafting and maintaining IRT specification and requirements documentation. This role requires someone who can independently manage multiple studies and priorities and become productive quickly with minimal ramp-up. ResponsibilitiesLead IRT activities for assigned clinical studies from initial system design and build through study closure.Draft, review, update, and maintain IRT system specifications and requirements documentation based on clinical study protocols and business requirements.Partner with clinical study teams, IRT vendors, and cross-functional stakeholders to translate study requirements into effective IRT system designs.Manage IRT system development timelines, deliverables, dependencies, risks, and study milestones.Develop and maintain IRT test scripts and lead/facilitate User Acceptance Testing (UAT) activities.Review testing results, identify system issues, and coordinate resolution with vendors and internal stakeholders.Support system changes, enhancements, integrations, and amendments throughout the clinical study lifecycle.Ensure IRT system designs comply with established standards, protocol requirements, SOPs, ICH guidelines, Good Clinical Practice (GCP), and applicable regulatory requirements.Coordinate with upstream and downstream clinical systems and functions to ensure appropriate data flow and system integration.Manage multiple concurrent studies and competing priorities while maintaining quality and meeting established timelines.Identify potential risks or issues affecting study timelines or system quality and proactively develop solutions.Serve as the IRT subject matter representative within cross-functional clinical study teams. Required QualificationsBachelor's degree in Life Sciences, Computer Science, Management Information Systems, Business, or a related field.3+ years of hands-on IRT/RTSM experience within clinical research or the biopharmaceutical industry.Candidates with 2+ years of IRT experience may be considered if coming directly from an IRT/RTSM vendor environment.Demonstrated experience drafting, updating, and managing IRT specification/requirements documentation.Experience managing IRT systems throughout the clinical study lifecycle, including initial build, implementation, maintenance, and study closure.Experience writing IRT system test scripts and facilitating or leading UAT testing efforts.Strong understanding of clinical trial processes and ICH/GCP practices.Demonstrated ability to independently manage multiple studies, assignments, timelines, and competing priorities.Strong project management, organizational, analytical, and communication skills.Ability to work effectively with clinical study teams, technical teams, vendors, and cross-functional stakeholders. Preferred QualificationsPMP certification.Experience working directly for an IRT/RTSM vendor.General knowledge of EDC and other clinical technology platforms.Experience supporting integrations between IRT and other clinical systems.Knowledge of clinical data standards and clinical system development processes. Ideal BackgroundSuccessful candidates will typically have experience as an IRT System Designer, IRT Lead, IRT Project Manager, IRT Requirements Analyst, RTSM Project Manager, IRT Business Analyst, or similar clinical systems professional. This position requires direct IRT design and specification experience. Candidates whose experience is primarily as a Clinical Research Associate (CRA) or who have only used IRT systems as an end user without responsibility for IRT specifications, system design, or implementation would not be an ideal fit. 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