IRT Lead for Clinical Trials

Job Summary

To support clinical trials, the contract remote IRT Lead for Clinical Trials will manage the design, implementation, and lifecycle of IRT/RTSM systems across multiple studies, ensuring efficient patient randomization and investigational product handling while collaborating with internal stakeholders and external vendors.

Key responsibilities

• Serve as project manager for IRT on assigned trials, overseeing study builds from kickoff through close-out
• Act as the primary liaison to external IRT vendors, managing timelines, deliverables, and configuration of study-specific modules
• Own IRT and RTSM as a business process, maintaining standard operating procedures and shaping the IRT digital roadmap

Required qualifications

• Bachelor's degree in life sciences, engineering, supply chain, information systems, or a related field
• Five or more years in clinical supply chain, clinical operations, or clinical systems, with hands-on IRT or RTSM ownership
• Demonstrated end-to-end delivery of IRT builds, including specification authoring and study operations support
• Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms
• Proven experience managing external IRT vendors and familiarity with GCP and computer system validation