IRT Clinical Supply Specialist - Operations
Location: Hybrid
Hyderabad or Noida
Function: Clinical Supply Operations / IRT
Why Join Us
Join a global, mission-driven organization that's redefining how clinical trials are executed through innovation, technology, and collaboration. In this role, you'll contribute to improving patient outcomes while developing your expertise at the intersection of clinical operations and digital health technology.
Role Purpose What Makes This Role Different
This is
not an IRT UAT/testing role. The
IRT Clinical Supply Specialist will act as the
bridge between Clinical Supply Chain and IRT systems, ensuring that drug supply strategies are correctly executed inside the IRT platform to support complex Phase IIV biotech studies.
You will manage
depot configuration, randomisation list loading, kit setup, resupply logic, forecasting and expiry management, ensuring that the
right drug reaches the right site at the right time, with full oversight of drug movement, site stock levels and patient safety.
You will work closely with clinical supply leads, study teams, depots and vendors to
translate supply strategies into IRT configuration, proactively identifying risks related to forecasting, expiry, resupply triggers or shipment planning.
Key Accountabilities
Clinical Supply Ownership Inside IRT (Primary Focus)
- Configure IRT for depot setup, kit types, batch/expiry management and resupply parameters
- Load randomization lists & allocation tables based on study protocols
- Execute supply forecasting logic to control drug flow and avoid over/under supply
- Monitor site stock levels and adjust resupply strategies accordingly
- Support shipment planning and escalation of supply issues directly with study teams
- Identify risks related to expiry, depot delays, country approvals or forecasting
- Ensure compliance with GxP and patient safety standards for all supply activities
IRT Testing & Validation (Supporting Function)
- Design and execute test scenarios for supply chain functionality (NOT only UAT)
- Validate resupply logic, expiry controls, forecasting and depot flows
- Maintain traceability between protocol supply strategy IRT setup testing
- Support design discussions to ensure configuration is testable and compliant
- Document issues, review defects and collaborate with study teams for resolution
Stakeholder Collaboration / Influence
- Act as the subject matter expert between supply chain teams and IRT developers
- Participate in vendor discussions and provide input on supply-related configuration
- Escalate ambiguities in protocol or supply plans proactively
- Contribute to improvements in IRT setup standards and supply chain templates
Decision-Making & Impact
- Configures supply parameters that directly impact patient dosing
- Owns expiry logic and site resupply strategies inside IRT
- Identifies issues that could delay shipment or risk IMP wastage
- Helps shape how future studies configure supply management in IRT systems
Essential Skills & Experience
Must-Have
- 57 years exp in clinical supplies / IRT operations
- Hands-on IRT configuration & supply setup experience
- Resupply algorithms / depot management / expiry management
- Understanding of randomisation & visit-level demand forecasting
- Experience working with CROs / pharma / RTSM vendors
- Strong ability to explain supply logic to study teams
- Stakeholder coordination with supply chain + study teams
Desirable
- Experience creating IRT supply playbooks/templates
- Improving supply processes & resupply strategies
- Vendor interaction and escalation experience
- Familiarity with forecasting methodologies or simulation tools
- Mentoring team members in supply chain/IRT operations
Who Will Succeed in This Role
- Someone who owns supply strategy inside IRT not just tests it
- Comfortable working with study teams, depots & vendors
- Understands why supply decisions are made not just how
- Has worked in clinical supply chain or RTSM/IRT configuration roles
- Wants visibility & impact on real biotech studies
How To Apply
If you have been the
bridge between IRT & clinical supply operations and want to shape how life-changing medicines reach patientsthis role is for you.
Why Join Us
Join a global, mission-driven organization that's redefining how clinical trials are executed through innovation, technology, and collaboration. In this role, you'll contribute to improving patient outcomes while developing your expertise at the intersection of clinical operations and digital health technology.
