- Location: California, United States
- Type: Contract
- Job ID: 10641
- Work Setting: On-Site
- Posted: September 29, 2026
- Closing Date: November 2, 2027
- Tax Status: W2
Senior IRT Manager
12 month contract
Remote, PST hours
Must be able to work on a W2
Summary
A Life Sciences organization has engaged GForce Life Sciences to provide a Senior Manager, Interactive Response Technology. This position is remote and responsible for owning the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV clinical trials, including integrations with adjacent clinical and enterprise platforms. The role supports study-level execution, vendor management, and governance, ensuring the efficient operation of patient randomization and investigational product handling throughout the trial portfolio.
Duties / Expectations of Role
Mandatory Requirements
Nice to Have
12 month contract
Remote, PST hours
Must be able to work on a W2
Summary
A Life Sciences organization has engaged GForce Life Sciences to provide a Senior Manager, Interactive Response Technology. This position is remote and responsible for owning the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV clinical trials, including integrations with adjacent clinical and enterprise platforms. The role supports study-level execution, vendor management, and governance, ensuring the efficient operation of patient randomization and investigational product handling throughout the trial portfolio.
Duties / Expectations of Role
- Serve as project manager for IRT on assigned trials, leading study builds from kickoff to close-out, and managing vendor and internal team adherence to timelines and deliverables.
- Collaborate with IT and study teams to translate protocols into User Requirement Specifications (URS), ensuring accurate capture of randomization, visit schedules, dosing regimens, stratification, unblinding rules, and drug supply configurations before system build.
- Act as primary liaison to external IRT vendors, overseeing build timelines, configuration of study-specific modules, and adherence to specifications.
- Develop test plans with IT and coordinate cross-functional UAT, ensuring all requirements are tested and defects are documented and resolved prior to go-live.
- Coordinate training and system access for site staff, monitors, and study teams, verifying role assignments before first patient in.
- Provide day-to-day oversight during trial conduct, monitoring enrollment, inventory, and troubleshooting issues with vendors and global study operations.
- Manage mid-study changes through formal change control processes, assessing impact, updating specifications, retesting, and securing approvals before implementation.
- Lead IRT close-out activities, including database lock, reconciliation, final inventory management, data archival, and system decommissioning.
- Maintain and improve IRT SOPs, work instructions, standards, test scripts, and training materials, integrating lessons learned from each study.
- Partner with Supply Chain Strategy & Excellence to shape the digital roadmap, assessing emerging features like platform integrations, direct-to-patient supply, and adaptive randomization.
- Lead vendor sourcing, RFQs/RFPs, assessments, feasibility evaluations, and platform selection, collaborating with Procurement and study teams on commercial terms and change orders.
- Act as subject matter expert on IRT, coaching study teams and partnering with Clinical Operations, Biostatistics, Data Management, IT, and Quality Assurance.
- Define and report KPIs such as system uptime, error rates, site stock-out events, and drug wastage; analyze IRT data to inform senior management on performance and trends.
- Represent IRT in cross-functional forums for protocol feasibility, risk management, and decentralized trial initiatives.
Mandatory Requirements
- Bachelor's degree in life sciences, engineering, supply chain, information systems, or related field.
- Five or more years in clinical supply chain, operations, or systems, including at least five years of hands-on IRT or RTSM ownership involving multiple concurrent studies.
- Proven experience delivering end-to-end IRT builds, from specification development through study support and close-out.
- Working knowledge of randomization, blinding methodologies, clinical demand forecasting, and IRT resupply algorithms.
- Experience managing external IRT vendors, including oversight of timeline, quality, and escalation processes.
- Familiarity with GCP, 21 CFR Part 11, computer system validation, and inspection readiness for clinical systems.
- Ability to work independently across global time zones, exercising judgment on escalation and aligning cross-functional teams.
Nice to Have
- Experience with multiple commercial IRT or RTSM platforms.
- Background in rare disease, gene therapy, or multi-region global trials.
- Exposure to direct-to-patient supply, decentralized trials, or adaptive designs.
- Experience integrating IRT with EDC, CTMS, ERP, or supply planning systems.