[Hiring] Senior Manager, Interactive Response Technology @Harvest Technical Services

Role Description

The company is engaging a hands-on Interactive Response Technology (IRT) Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM (randomization and trial supply management) systems across Phase I–IV clinical trials, including the integrations that connect them to adjacent clinical and enterprise platforms. This is an individual contributor engagement: the person in this seat does the work, rather than directing a team that does it. The role sits at the intersection of Clinical Supply Chain, Global Study Operations, IT, and Supply Chain Strategy & Excellence, and carries end-to-end responsibility for IRT across the trial portfolio.

Day to day, that means making sure patient randomization and investigational product handling run cleanly at the study level. Over the course of the engagement, it also means raising the standard — building the templates/standards, governance routines, and best practices that let IRT scale beyond any single trial. Success depends as much on cross-functional influence as on technical depth. This is a contract position. The IRT Lead partners closely with internal stakeholders and external vendors but does not manage company employees.

Responsibilities

• Serve as project manager for IRT on each assigned trial, leading study builds and support from kickoff through close-out, and holding both the vendor and the internal team to the study timeline.
• Partner with IT and study teams to translate protocols into User Requirement Specifications (URS).
• Act as the primary liaison to external IRT vendors, managing build timelines and deliverables.
• Develop test plans with IT and orchestrate cross-functional User Acceptance Testing (UAT).
• Coordinate training and system access for site staff, monitors, and study teams.
• Provide day-to-day oversight during trial conduct: monitor enrollment and inventory through IRT dashboards.
• Act as the Clinical Supply Chain (CSC) single point of contact for all IRT-related activities.
• Continuously refine the IRT resupply parameters with Clinical Supply Chain (CSC).
• Manage mid-study changes through formal change control process for protocol amendments.
• Lead IRT close-out alongside IT: database lock, IRT-to-EDC reconciliation, final investigational product accountability, data archival, and formal system decommissioning.

Portfolio Standards and Governance

• Own IRT and RTSM as a business process for the organization.
• Partner with the Head of Digital & Analytics in Supply Chain Strategy & Excellence to shape the IRT digital roadmap.
• Define the multi-year direction for IRT capability, assessing emerging features.
• Lead IRT vendor sourcing activities, including participation in RFQs/RFPs.
• Run vendor governance: hold regular service reviews, monitor performance against agreed KPIs.
• Serve as the organization's subject matter expert on IRT.
• Define and report functional KPIs — system uptime, randomization error rate, site stock-out events, drug wastage.
• Represent IRT in cross-functional forums.

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.
• Demonstrated end-to-end delivery of IRT builds.
• Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms.
• Proven experience managing external IRT vendors.
• Familiarity with GCP, 21 CFR Part 11, computer system validation, and inspection readiness expectations for clinical systems.
• Ability to work independently across global time zones.

Requirements

• Hands-on experience with more than one commercial IRT or RTSM platform.
• Rare disease, gene therapy, or global multi-region trial experience.
• Exposure to direct-to-patient supply models, decentralized trials, or adaptive designs.
• Experience with IRT integrations to EDC, CTMS, and ERP or supply planning systems.

Benefits

• The hiring range for this position is $70 to $79.31 per hour.
• The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Company Description

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.