Sr. Manager, Interactive Response Technology

Sr. Manager, Interactive Response Technology (IRT/RTSM)

Location: 100% Remote
Duration: 12-Month Contract
Pay Rate: $80.00 $83.00/hour
Position Type: Individual Contributor / Hands-On Technical Lead

Position Overview

We are seeking an experienced Interactive Response Technology (IRT/RTSM) Lead to manage the design, build, implementation, support, and lifecycle management of IRT/RTSM systems supporting Phase I IV clinical trials.

This is a hands-on individual contributor role, not a people-management position. The successful candidate will personally lead IRT activities across multiple clinical studies, partnering with Clinical Supply Chain, Clinical Operations, IT, Biostatistics, Data Management, Quality, and external IRT vendors.

The role requires strong expertise in patient randomization, blinding, clinical trial supply management, IRT system builds, UAT, integrations, resupply strategies, vendor management, change control, and study closeout.

Key Responsibilities

• Lead end-to-end IRT/RTSM implementation and lifecycle management for multiple concurrent clinical trials, from study kickoff through closeout.
• Translate clinical protocols into detailed User Requirement Specifications (URS) covering randomization, visit schedules, dosing, stratification, unblinding, and drug supply requirements.
• Manage external IRT vendors, including study builds, timelines, deliverables, system configuration, quality, issue resolution, and escalations.
• Develop testing strategies and lead cross-functional User Acceptance Testing (UAT) prior to system go-live.
• Coordinate IRT training, user access, and blinded/unblinded system roles for study teams, monitors, and clinical sites.
• Provide ongoing study support by monitoring enrollment, randomization, dosing, inventory, and clinical supply through IRT dashboards.
• Partner with Clinical Supply Chain to optimize IRT resupply parameters, reduce drug wastage, and prevent site stock-outs.
• Manage protocol amendments and mid-study IRT changes through formal change-control processes.
• Lead study closeout activities, including database lock, IRT-to-EDC reconciliation, investigational product accountability, archival, and system decommissioning.
• Maintain IRT/RTSM SOPs, work instructions, standards, test scripts, training materials, and best practices.
• Support IRT vendor selection, RFQs/RFPs, vendor assessments, governance, service reviews, and performance KPIs.
• Serve as an IRT/RTSM subject matter expert, partnering with Clinical Operations, Biostatistics, Data Management, IT, Quality Assurance, and Supply Chain.
• Support integrations between IRT and systems such as EDC, CTMS, ERP, and clinical supply planning platforms.
• Track and report IRT performance metrics, including system uptime, randomization errors, site stock-outs, and drug wastage.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Supply Chain, Information Systems, or related field.
• 5+ years of hands-on IRT/RTSM experience supporting multiple concurrent clinical studies.
• Demonstrated end-to-end ownership of IRT studies, including:
  • Requirements/URS development
  • System configuration/build oversight
  • UAT/testing
  • Go-live
  • Study support
  • Change control
  • Study closeout and reconciliation
• Strong understanding of randomization, blinding, clinical supply forecasting, and IRT resupply algorithms.
• Experience managing external IRT/RTSM vendors.
• Knowledge of GCP, 21 CFR Part 11, computer system validation (CSV), and clinical inspection readiness.
• Ability to independently manage projects and collaborate across global, cross-functional teams.

Preferred Qualifications

• Experience with multiple commercial IRT/RTSM platforms.
• Rare disease, gene therapy, or global/multi-region clinical trial experience.
• Experience with decentralized clinical trials, adaptive trial designs, or direct-to-patient clinical supply.
• Experience integrating IRT/RTSM with EDC, CTMS, ERP, or supply planning systems.