Note: The job is a remote job and is open to candidates in USA. Signant Health is a global evidence generation company that supports clinical trials with smart technology and scientific expertise. The IRT Clinical Supplies Manager will ensure drug supply strategies are accurately configured and executed within the IRT platform to support clinical studies, collaborating closely with study teams and vendors to maintain compliance and patient safety.
Responsibilities
- Configure IRT systems for depot setup, kit types, batch and expiry management, and resupply parameters
- Load randomization lists and allocation tables in alignment with study protocols
- Execute and manage supply forecasting to ensure optimal drug availability and minimize waste
- Monitor site stock levels and proactively adjust resupply strategies
- Support shipment planning and escalate supply risks or issues to stakeholders
- Identify and mitigate risks related to expiry, depot delays, forecasting, and country approvals
- Ensure compliance with GxP standards and patient safety requirements
- Design and execute test scenarios for supply chain functionality within IRT
- Validate resupply logic, forecasting, expiry controls, and depot workflows
- Maintain traceability between protocol, supply strategy, system configuration, and testing
- Document and track issues, collaborating with teams to resolve defects
- Act as a subject matter expert between clinical supply teams and IRT system stakeholders
- Collaborate with vendors and internal teams on supply-related configurations
- Provide input into process improvements and standardization of IRT supply setup
Skills
- Configure IRT systems for depot setup, kit types, batch and expiry management, and resupply parameters
- Load randomization lists and allocation tables in alignment with study protocols
- Execute and manage supply forecasting to ensure optimal drug availability and minimize waste
- Monitor site stock levels and proactively adjust resupply strategies
- Support shipment planning and escalate supply risks or issues to stakeholders
- Identify and mitigate risks related to expiry, depot delays, forecasting, and country approvals
- Ensure compliance with GxP standards and patient safety requirements
- Design and execute test scenarios for supply chain functionality within IRT
- Validate resupply logic, forecasting, expiry controls, and depot workflows
- Maintain traceability between protocol, supply strategy, system configuration, and testing
- Document and track issues, collaborating with teams to resolve defects
- Act as a subject matter expert between clinical supply teams and IRT system stakeholders
- Collaborate with vendors and internal teams on supply-related configurations
- Provide input into process improvements and standardization of IRT supply setup
- Bachelor's degree or equivalent relevant experience
- 5–7 years of experience in clinical supplies, IRT, or RTSM operations
- Hands-on experience with IRT configuration and supply setup
- Strong understanding of resupply algorithms, depot management, and expiry management
- Experience with randomization processes and visit-level demand forecasting
- Experience working with CROs, pharmaceutical companies, or IRT vendors
- Strong communication and stakeholder management skills
Company Overview