| Location | San Rafael, CA (Remote) |
Senior Manager, Interactive Response Technology (IRT/RTSM)
Location: 100% Remote
Contract: 12-month W2 assignment
Pay Rate: $76/hour DOE & location
About the Role
Seeking an experienced IRT/RTSM professional to manage the design, implementation, and lifecycle of Interactive Response Technology systems supporting Phase I IV clinical trials. This is a hands-on individual contributor role with responsibility for IRT activities from study setup through closeout.
Responsibilities
" Lead IRT/RTSM activities from study kickoff through closeout.
" Translate clinical protocols into User Requirement Specifications (URS).
" Manage IRT vendors, study builds, timelines, configurations, and deliverables.
" Develop test plans and lead User Acceptance Testing (UAT).
" Support randomization, blinding, dosing, enrollment, inventory, and drug resupply activities.
" Troubleshoot IRT issues during active clinical trials.
" Manage system changes resulting from protocol amendments.
" Partner with Clinical Supply Chain to optimize inventory and resupply strategies.
" Lead IRT closeout, reconciliation, archival, and decommissioning activities.
" Maintain IRT standards, SOPs, work instructions, test scripts, and training materials.
" Partner with Clinical Operations, Supply Chain, IT, Data Management, Biostatistics, Quality, and external vendors.
Required Qualifications
" Bachelor's degree in life sciences, engineering, supply chain, information systems, or related field.
" 5+ years of hands-on IRT/RTSM experience across multiple clinical studies.
" End-to-end IRT experience including URS, study builds, UAT, go-live, study support, change control, and closeout.
" Knowledge of randomization, blinding, clinical drug supply, forecasting, and IRT resupply strategies.
" Experience managing external IRT/RTSM vendors.
" Knowledge of GCP, 21 CFR Part 11, computer system validation, and clinical system compliance.
" Strong project management, communication, and cross-functional collaboration skills.
Preferred Qualifications
" Experience with multiple commercial IRT/RTSM platforms.
" Rare disease, gene therapy, or global clinical trial experience.
" Experience with IRT integrations to EDC, CTMS, ERP, or supply planning systems.
" Experience with decentralized trials, direct-to-patient supply, drug pooling, or adaptive trial designs.