IRT Clinical Supplies Specialist – Operations
Location: Hybrid – Hyderabad or Noida, India
Employment Type: Permanent
Function: Clinical Supply Operations / IRT
Experience Required: 5–7 Years
Job Overview
We are seeking an experienced IRT Clinical Supplies Specialist to serve as the critical link between Clinical Supply Chain operations and IRT systems for complex Phase I–IV biotech studies. This role ensures that drug supply strategies are correctly executed within the IRT platform, supporting patient safety, site stock management, and accurate resupply.
The ideal candidate will have hands-on experience in IRT configuration, clinical supply management, and resupply forecasting, and will work closely with study teams, depots, vendors, and clinical supply leads to translate supply strategies into actionable IRT setups.
Key Responsibilities
1. Clinical Supply Management in IRT (Primary Focus)
Configure IRT for depot setup, kit types, batch/expiry management, and resupply parameters.
Load randomization lists and allocation tables according to study protocols.
Execute supply forecasting logic to control drug flow and prevent over- or under-supply.
Monitor site stock levels and adjust resupply strategies proactively.
Support shipment planning and escalate supply issues to study teams as needed.
Identify risks related to expiry, depot delays, country approvals, or forecasting.
Ensure compliance with GxP and patient safety standards for all supply activities.
2. IRT Testing & Validation (Supporting Function)
Design and execute test scenarios for supply chain functionality, beyond standard UAT.
Validate resupply logic, expiry controls, forecasting, and depot flows.
Maintain traceability from protocol → supply strategy → IRT setup → testing.
Document issues, review defects, and collaborate with study teams for timely resolution.
3. Stakeholder Collaboration & Influence
Act as the subject matter expert bridging 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 process improvements, supply templates, and standard operating procedures for IRT configuration.
4. Decision-Making & Impact
Configure supply parameters that directly impact patient dosing.
Own expiry logic and site resupply strategies in IRT.
Identify risks that could delay shipments or result in IMP wastage.
Influence how future studies configure clinical supply management in IRT systems.
Required Skills & Experience
Must-Have:
5–7 years of experience in clinical supply operations or IRT/RTSM configuration.
Hands-on experience with IRT setup, depot management, resupply algorithms, and expiry management.
Knowledge of randomization, visit-level demand forecasting, and clinical supply chain workflows.
Experience coordinating with CROs, pharma companies, or RTSM vendors.
Strong ability to explain supply logic and interact with study teams effectively.
Desirable:
Experience creating IRT supply playbooks or templates.
Process improvement and optimization of resupply strategies.
Vendor interaction and escalation management experience.
Familiarity with forecasting methodologies or simulation tools.
Mentoring junior team members in IRT operations or clinical supply management.
Ideal Candidate Profile
Takes ownership of supply strategy inside IRT, not just testing.
Comfortable working with study teams, depots, and vendors.
Understands the rationale behind supply decisions, not just the procedures.
Experienced in clinical supply chain operations and RTSM/IRT configuration.
Seeks visibility and impact on life-changing biotech studies.
Why Join
Work at the intersection of clinical operations and digital health technology.
Contribute to improving patient outcomes by ensuring accurate drug supply.
Collaborate with global teams and gain exposure to advanced clinical supply systems.
Be part of a mission-driven organization that celebrates diversity and promotes equal opportunity.
Explore more global clinical supply, RTSM, and biotech operations roles at
thepharmadaily.com
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