The IRT/eCOA Systems Manager will be part of the GCDO Clinical Data Operations department. The EDC programming team handles the implementation, validation, and ongoing support of Interactive Response Technology (IRT) and electronic Clinical Outcomes Assessment (eCOA) systems used in clinical trials. This role is part of the EDC programming group. It works closely with Clinical Operations, Data Management, and external vendors to ensure high-quality randomization, drug supply management, and patient-reported outcome data.

Essential Functions

System Strategy and Governance

• Develop and maintain the strategy, standards, and operating model for IRT and eCOA systems across Jazz clinical programs.

• Define governance frameworks for study setup, change control, integrations, and data flows.

• Ensure compliance with regulatory and quality requirements such as GxP, 21 CFR Part 11, GDPR, and organizational SOPs.

• Contribute to BID defenses and vendor selection, ensuring technical, operational, and quality criteria are met.

Study Start-Up and Build Management

•  Review and translate protocol requirements into IRT/eCOA system specifications.

• Lead build design and specification activities, ensuring requirements are accurately documented and aligned with protocol needs.

• Oversee or lead system configuration, validation documentation, UAT assistance (User Acceptance Testing), and deployment for Phase 1–4 studies.

• Maintain standardized libraries, templates, visit schedules, and device provisioning rules to support rapid project startup.

• Ensure seamless integration with Rave EDC, Jazz CDF, RTSM, and Medidata Visual Analytics platforms.

Vendor and Stakeholder Management

•  Manage relationships with IRT/eCOA vendors (e.g., Medidata RTSM, Endpoint, Suvoda, Clario, IQVIA).

• • Oversee timelines, deliverables, KPIs, and escalation processes.

• • Support vendor selection through technical evaluations, RFP participation, and comparative assessments.

• Collaborate with cross-functional partners, including Clinical Operations and QA, throughout the study lifecycle.

• Provide training and guidance to internal teams on IRT/eCOA capabilities and processes.

Operational Oversight and Support

• When needed, monitor system performance, enrollment trends, drug supply metrics, and device logistics.

• Resolve issues related to randomization, kit shortages, dosing windows, diary compliance, technical defects, and system integrations.

• Manage mid-study updates, data extracts, reconciliations, and audit readiness activities.

• Maintain all required documentation related to system validation, change control, requirements, and issue management.

• Provide ongoing support throughout the study duration for both IRT and eCOA, ensuring continuity, compliance, and minimal disruption to trial operations.

Continuous Improvement

• Identify opportunities to enhance processes through automation, AI-driven design support, and standardized configuration libraries.

• Drive process optimization initiatives to increase quality and reduce cycle times.

• Ensure lessons learned are captured and applied across ongoing and future programs.

Required Knowledge, Skills, and Abilities

•  7+ years of experience in IRT, eCOA, Clinical Data Management, or clinical systems implementation.

• Strong understanding of clinical trial operations, patient visit schedules, and drug supply logistics.

• Deep knowledge of IRT systems (e.g., Medidata RTSM, Suvoda, Endpoint, IQVIA) and eCOA/ePRO platforms.

• Ability to interpret clinical protocols and translate requirements into system designs, specifications, and test plans.

• Hands-on experience with system build activities, including requirements drafting, design review, configuration oversight, and UAT support.

• Knowledge of integration models across EDC, IRT, eCOA, and other clinical systems.

• Strong understanding of regulatory and compliance frameworks: GxP, 21 CFR Part 11, GDPR, ALCOA+, computer system validation (CSV), and audit readiness.

• Proven ability to manage vendors, evaluate bids, and contribute to vendor selection processes.

• Skills in issue management, risk assessment, root-cause analysis, and executing mid-study changes.

• Skilled in documentation practices, including validation artifacts, requirements, specifications, change controls, and operational logs.

• Proficient in supporting study teams throughout the trial lifecycle and guiding system usage, data flows, and operational troubleshooting.

• Strong analytical skills for reviewing system performance, enrollment trends, device compliance, and drug supply forecasts.

• Excellent communication skills for collaborating with cross-functional teams such as Clinical Operations, and QA.

• Capable of managing multiple studies simultaneously, prioritizing workloads, and working in fast-paced environments.

• Strong problem-solving skills focused on quality, consistency, and operational efficiency.

Required/Preferred Education and Licenses:

Qualifications:

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field.

• An advanced degree is preferred but not required

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