Remote IRT Lead - End-to-End Clinical Trial Systems

BioMarin Pharmaceutical Inc.; Northern (KY); Hybrid; USD 110,000 - 179,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking an IRT Lead on a contract basis to own the design, build, and lifecycle management of IRT/RTSM systems across Phase I–IV trials.

The role interfaces with Clinical Supply Chain, Global Study Operations, IT, and Quality Assurance, and requires strong vendor management and cross-functional collaboration to ensure clean randomization and proper drug supply configuration. The position is remote for a duration of 1 year plus, with the person acting as an

Qualifications

• Minimum five years in clinical supply chain or operations with hands-on IRT/RTSM ownership.
• End-to-end IRT delivery including spec, test, go-live, and close-out.
• Familiar with randomization, blinding design, and IRT resupply algorithms.

Responsibilities

• Act as study-level IRT project manager across assigned trials, from kickoff to close-out.
• Translate protocols into URS and ensure correct DRG, dosing, and visit schedules before build.
• Coordinate with external IRT vendors and internal study teams to meet timelines.
• Develop test plans and lead UAT for URS-defined requirements.
• Coordinate training and access for site staff and monitors, ensuring correct roles.

Skills

Project management

Vendor management

Cross-functional collaboration

Communication skills

Independent work across time zones

Education

Bachelor’s degree in life sciences, engineering, supply chain, information systems, or related field

Tools

GCP

21 CFR Part 11

Computer system validation

Inspection readiness

Job description

BioMarin Pharmaceutical Inc. is seeking an IRT Lead on a contract basis to own the design, build, and lifecycle management of IRT/RTSM systems across Phase I–IV trials.

The role interfaces with Clinical Supply Chain, Global Study Operations, IT, and Quality Assurance, and requires strong vendor management and cross-functional collaboration to ensure clean randomization and proper drug supply configuration. The position is remote for a duration of 1 year plus, with the person acting as an