Senior Manager, Interactive Response Technology, Clinical Trials

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the design, development, implementation, and lifecycle management of IRT/RTSM systems for Phase I–IV clinical trials.

• Oversee integrations that connect IRT/RTSM systems to related clinical and enterprise platforms.

• Act as the project manager for IRT on designated trials from initiation to completion.

• Convert protocols into User Requirement Specifications that encompass randomization, visit schedules, dosing regimens, stratification, unblinding, and drug supply configuration.

• Collaborate with external IRT vendors and oversee study build timelines, deliverables, and system configuration.

• Create test plans and lead cross-functional User Acceptance Testing activities.

• Organize training and system access for site personnel, monitors, and study teams.

• Track enrollment and inventory via IRT dashboards and resolve trial-related issues.

• Act as the single point of contact for Clinical Supply Chain regarding IRT activities.

• Optimize IRT resupply parameters to minimize site stock-outs and control overages.

• Manage changes to protocols through formal change control processes.

• Direct IRT close-out activities, including database lock, IRT-to-EDC reconciliation, product accountability, archival, and decommissioning.

• Maintain IRT/RTSM procedures, work instructions, standards, test scripts, and training documentation.

• Define the IRT digital roadmap and long-term capability strategy.

• Lead the sourcing, assessment, platform selection, and governance of IRT vendors.

• Act as the subject matter expert for IRT within the organization and mentor cross-functional teams.

• Establish and report on functional KPIs, such as system uptime, randomization error rate, stock-outs, and drug wastage.

• Represent IRT in discussions about protocol feasibility, risk management, and digital trial initiatives.

⛳️ Requirements

• Bachelor's degree in life sciences, engineering, supply chain, information systems, or a related discipline.

• A minimum of five years in clinical supply chain, clinical operations, or clinical systems.

• At least five years of direct experience in IRT or RTSM management across multiple concurrent studies.

• Proven track record in the end-to-end delivery of IRT builds, including specification writing, test leadership, go-live, study operations and support, mid-study change control, and close-out reconciliation.

• Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms.

• Established experience in managing external IRT vendors, focusing on timelines, deliverables, quality, and escalation processes.

• Familiarity with GCP, 21 CFR Part 11, computer system validation, and readiness for inspections concerning clinical systems.

• Ability to operate independently across global time zones.

• Strong judgment to escalate issues early and effective communication skills to coordinate with functions outside of this role.

• Practical experience with more than one commercial IRT or RTSM platform (preferred).

• Experience in rare diseases, gene therapy, or global multi-region trials (preferred).

• Knowledge of direct-to-patient supply models, decentralized trials, or adaptive designs (preferred).

• Familiarity with IRT integrations to EDC, CTMS, and ERP or supply planning systems (preferred).

🏝️ Benefits

• One-year contract engagement with the potential for extension.

• Full-time temporary employment opportunity.

• Equal employment opportunity protections.

• Participation in environmental, health, and safety initiatives and training.