Senior IRT Clinical Supply Manager

Discover International; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Discover International seeks a Manager Clinical Supply, IRT for a 12-month contract. The position is remote but may require travel to the Bay Area (about one week per month) to support site activations and governance.

The ideal candidate will lead strategy, design, configuration, and lifecycle management of IRT systems for global trials, drive inventory and risk-based improvements, and ensure regulatory compliance across FDA/EMA/GMP standards.

Qualifications

• Proven ability to translate complex protocol requirements into functional IRT specifications, ensuring seamless integration of randomization, site activation, and supply management.
• Collaborate cross-functionally with Clinical Operations, Supply Chain, QA, and vendors to align system design with study objectives and operational needs.
• Lead IRT governance, including system enhancements, change control processes, and impact assessments to maintain operational efficiency and compliance.
• Drive inventory strategies within IRT, incorporating resupply logic, buffer stock, expiry management, and packaging configurations.
• Oversee vendor relationships, ensuring timely delivery of specifications, validation, and system updates through effective communication and leadership.
• Direct User Acceptance Testing (UAT) and validation activities, ensuring systems meet regulatory and quality standards.
• Monitor live study performance, troubleshooting IRT-related issues to prevent disruptions in drug supply, dosing, and site operations.
• Ensure inspection readiness through robust documentation, audit trails, and adherence to FDA, EMA, and GMP requirements.
• Apply risk-based thinking and data analytics to optimize supply chain performance, mitigate risks, and drive continuous improvement across clinical trials.

Responsibilities

• Oversee end-to-end IRT activities across global trials.
• Collaborate with cross-functional teams to align system design with study objectives.
• Manage governance, changes, and risk assessments for IRT systems.
• Optimize inventory and resupply strategies within IRT.
• Maintain relationships with vendors and ensure timely updates and validation.
• Lead UAT and validation to meet regulatory requirements.
• Monitor study performance and troubleshoot IRT-related issues.
• Ensure inspection readiness with documentation and audit trails.
• Apply data analytics to improve supply chain performance.

Skills

IRT systems

Governance

UAT

Validation

Vendor management

Data analytics

Regulatory compliance

Drug supply

Tools

FDA

EMA

GMP

Job description

Discover International seeks a Manager Clinical Supply, IRT for a 12-month contract. The position is remote but may require travel to the Bay Area (about one week per month) to support site activations and governance.

The ideal candidate will lead strategy, design, configuration, and lifecycle management of IRT systems for global trials, drive inventory and risk-based improvements, and ensure regulatory compliance across FDA/EMA/GMP standards.