Remote IRT Lead for Global Clinical Trials (Contract)

BioMarin Pharmaceutical Inc.; United States; Remote; USD 110,000 - 180,000; Full time

Job summary

BioMarin is seeking an IRT Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV trials. This contract role sits at the intersection of Clinical Supply Chain, Global Study Operations, IT, and Supply Chain Strategy & Excellence, driving scale and efficiency in trial supply processes.

As an individual contributor, you will coordinate with internal teams and external vendors, ensure correct randomization and product handling, and lead

Qualifications

• Bachelor's degree in life sciences, engineering, supply chain, information systems, or a related field.
• Five or more years in clinical supply chain or clinical operations, with hands-on IRT/RTSM ownership across multiple concurrent studies.
• Demonstrated end-to-end delivery of IRT builds: specification, testing, go-live, study operations and support, change control, and close-out reconciliation.
• Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms.
• Experience managing external IRT vendors, including timelines, deliverables, quality, and escalation management.
• Familiarity with GCP, 21 CFR Part 11, computer system validation, and inspection readiness for clinical systems.
• Ability to work independently across global time zones and align cross-functional teams.

Responsibilities

• Serve as project manager for IRT on each assigned trial, leading study builds and support from kickoff through close-out.
• Translate protocols into URS, confirming randomization design, visit schedule, dosing regimens, stratification factors, unblinding rules, and drug supply configuration.
• Liaise with external IRT vendors, manage build timelines and deliverables, oversee study-specific modules against specifications.
• Develop test plans with IT and lead cross-functional UAT covering URS requirements, including drug resupply, reports, and integrations.
• Coordinate training and system access for site staff, monitors, and study teams, ensuring correct blinded/unblinded roles.
• Provide day-to-day oversight during trial conduct: monitor enrollment and inventory via IRT dashboards, troubleshoot issues with vendors and GSO.
• Represent CSC in cross-functional discussions and refine resupply parameters to minimize stock-outs and overages.
• Lead mid-study changes through formal change control, communicate with teams, and secure approvals and budgets before implementation.
• Lead IRT close-out with IT: lock database, reconcile IRT-EDC, archive data, and decommission systems.

Skills

IRT/RTSM ownership

Vendor management

Cross-functional coordination

Documentation & testing

GCP knowledge

Education

Bachelor's degree in life sciences or related field

Tools

EDC systems

CTMS

ERP systems

Job description

BioMarin is seeking an IRT Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV trials. This contract role sits at the intersection of Clinical Supply Chain, Global Study Operations, IT, and Supply Chain Strategy & Excellence, driving scale and efficiency in trial supply processes.

As an individual contributor, you will coordinate with internal teams and external vendors, ensure correct randomization and product handling, and lead