IRT eCOA Systems Manager

Role Summary

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 works closely with Clinical Operations, Data Management, and external vendors to ensure high-quality randomization, drug supply management, and patient-reported outcome data.

Responsibilities

• 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 regulatory and quality compliance (GxP, 21 CFR Part 11, GDPR, SOPs).
• Contribute to vendor defenses and selection, ensuring technical, operational, and quality criteria are met.

• Review protocol requirements and translate into IRT/eCOA system specifications; lead build design and documentation; oversee configuration, validation documentation, UAT, and deployment for Phase 1–4 studies.
• Maintain standardized libraries, templates, visit schedules, and device provisioning rules for rapid startup; ensure integration with Rave EDC, Jazz CDF, RTSM, and Medidata Visual Analytics.

• Manage relationships with IRT/eCOA vendors; oversee timelines, deliverables, KPIs, and escalation processes.
• Support vendor selection through evaluations, RFPs, and assessments; collaborate with Clinical Operations and QA; provide training on IRT/eCOA capabilities.

• Monitor system performance, enrollment trends, drug supply metrics, and device logistics; resolve issues related to randomization, kit shortages, dosing windows, diary compliance, defects, and integrations.
• Manage mid-study updates, data extracts, reconciliations, and audit readiness; maintain documentation for validation, change control, requirements, and issue management; provide ongoing study support for IRT and eCOA.

• Identify opportunities to enhance processes through automation and standardized configuration libraries; drive process optimization to improve quality and reduce cycle times.

Qualifications

• Required: 7+ years of experience in IRT, eCOA, Clinical Data Management, or clinical systems implementation.
• Required: Strong understanding of clinical trial operations, patient visit schedules, and drug supply logistics.
• Required: Deep knowledge of IRT systems (e.g., Medidata RTSM, Suvoda, Endpoint, IQVIA) and eCOA/ePRO platforms.
• Required: Ability to interpret clinical protocols and translate requirements into system designs, specifications, and test plans.
• Required: Hands-on experience with system build activities, including requirements drafting, design review, configuration oversight, and UAT support.
• Required: Knowledge of integration models across EDC, IRT, eCOA, and other clinical systems.
• Required: Strong understanding of regulatory and compliance frameworks (GxP, 21 CFR Part 11, GDPR, ALCOA+, CSV) and audit readiness.
• Required: Proven ability to manage vendors, evaluate bids, and contribute to vendor selection processes.
• Required: Skills in issue management, risk assessment, root-cause analysis, and mid-study changes.
• Required: Documentation proficiency for validation artifacts, requirements, specifications, change controls, and operational logs.
• Required: Ability to support study teams throughout the trial lifecycle and guide system usage, data flows, and troubleshooting.
• Required: Strong analytical skills for reviewing system performance, enrollment trends, device compliance, and drug supply forecasts.
• Required: Excellent communication for collaboration with Clinical Operations and QA; ability to manage multiple studies in fast-paced environments.
• Required: Strong problem-solving skills focused on quality, consistency, and operational efficiency.

Education

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field.
• Advanced degree preferred but not required.