Note: The job is a remote job and is open to candidates in USA. BioMarin Pharmaceutical Inc. is a rare disease biotechnology company focused on developing therapies for genetically defined conditions. The role owns the design, implementation, and lifecycle management of Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) systems across clinical trials, while coordinating vendors, cross-functional stakeholders, governance, testing, and operational support.
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), confirming that the randomization design, visit schedule, dosing regimens, stratification factors, unblinding rules, and drug supply configuration are captured accurately before the build begins
- Act as the primary liaison to external IRT vendors, managing build timelines and deliverables, and overseeing configuration of study-specific modules against the approved specification. Also manage the internal study team to ensure adherence to the same build timelines and deliverables
- Develop test plans with IT and orchestrate cross-functional User Acceptance Testing (UAT) covering all requirements defined in the URS, including drug resupply, reports, and system integrations, with every defect documented and resolved before go-live
- Coordinate training and system access for site staff, monitors, and study teams, verifying that blinded and unblinded roles are correctly assigned before first patient in
- Provide day-to-day oversight during trial conduct: monitor enrollment and inventory through IRT dashboards, troubleshoot enrollment, dosing, and inventory issues with vendors and global study operations (GSO)
- Act as the Clinical Supply Chain (CSC) single point of contact for all IRT-related activities, representing CSC in cross-functional discussion. Continuously refine the IRT resupply parameters with Clinical Supply Chain (CSC) to prevent site stock-outs and reduce overages
- Manage mid-study changes through formal change control process for protocol amendments by assessing cross-functional impact, updating specifications, retesting, and securing approvals and budget allocation before implementation, with clear communication to study teams and sites
- Lead IRT close-out alongsideIT: database lock, IRT-to-EDC reconciliation, final investigational product accountability, data archival, and formal system decommissioning
- Own IRT and RTSM as a business process for the organization: maintain the standard operating procedures, work instructions, IRT standards, test scripts, and training materials, and fold lessons learned from each study back into them
- Partner with the Head of Digital & Analytics in Supply Chain Strategy & Excellence to shape the IRT digital roadmap and its place in the wider Global Supply Chain (GSC) ecosystem. That group sets the operational framework; this role drives execution and surfaces mitigations where roadblocks appear
- Define the multi-year direction for IRT capability, assessing emerging features such as platform integrations, direct-to-patient supply, drug pooling, and adaptive randomization, and building the case for those that measurably improve efficiency, patient experience, and/or data quality
- Lead IRT vendor sourcing activities, including participation in RFQs/RFPs, vendor assessments, feasibility evaluations, and study-specific platform selection in partnership with Procurement, IT, and study teams. Also, run vendor governance: hold regular service reviews, monitor performance against agreed KPIs, and escalate issues. Commercial terms and change orders are shaped with Procurement and executed by BioMarin employees
- Serve as the organization's subject matter expert on IRT, coaching study teams and partnering with Clinical Operations on randomization and blinding design, Biostatistics and Data Management on data integration and validation, and IT and Quality Assurance on system validation and compliance
- Define and report functional KPIs — system uptime, randomization error rate, site stock-out events, drug wastage — and turn IRT data into usable insight for senior management on supply performance, enrollment progress, and emerging trends
- Represent IRT in cross-functional forums so that randomization and trial supply implications are weighed during protocol feasibility, risk management, and digital trial initiatives such as decentralized and adaptive designs
Skills
- 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, including at least five years of hands-on IRT or RTSM ownership across multiple concurrent studies
- Demonstrated end-to-end delivery of IRT builds: specification authoring, test leadership, go-live, study operations and support, mid-study change control, and close-out reconciliation
- Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms
- Proven experience managing external IRT vendors, including timeline, deliverables, quality, and escalation management
- 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, with the judgment to escalate early and the communication skills to align functions that do not report to this role
- 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
- Remote work arrangement
Company Overview
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