IRT Clinical Supply Specialist – Operations
Job Title: IRT Clinical Supplies Manager
Requisition ID: 3792
Location: Hyderabad, Telangana, India (APAC Region)
Employment Type: Full-time | Regular
Function: Global Technical Delivery – Clinical Supply & IRT Operations
Travel Requirement: Up to 15% (International)
Experience Required: 5–7 Years
Job Overview
We are seeking an experienced IRT Clinical Supply Specialist – Operations to support the design, testing, and validation of Interactive Response Technology (IRT) systems for global Phase I–IV clinical trials. This role plays a critical part in ensuring patient safety and uninterrupted investigational medicinal product (IMP) supply by translating clinical trial protocols and supply chain strategies into robust, testable IRT system configurations.
The successful candidate will bring strong expertise in IRT systems, clinical supply chain operations, and GxP-compliant testing, acting as a key interface between study teams, technical delivery functions, and external IRT vendors.
Key Responsibilities
IRT Testing & System Validation
Analyze clinical trial protocols to identify IRT-related requirements including randomization, blinding, treatment allocation, dosing schedules, and visit structures
Translate protocol and clinical supply strategies into detailed technical specifications and acceptance criteria
Design and execute comprehensive IRT test cases covering positive, negative, boundary, and edge-case scenarios
Clinical Supply Chain Testing
Validate clinical supply strategies through IRT testing, including depot management, site resupply triggers, expiry handling, temperature excursion workflows, and product returns or destruction
Develop realistic test data and patient scenarios reflecting real-world trial complexity
Maintain a structured test case repository and traceability matrix linking protocol requirements to system functionality
Cross-Functional Collaboration
Serve as a subject matter expert and primary liaison between study teams, supply chain stakeholders, and IRT development vendors
Identify protocol ambiguities or operational gaps that may impact IRT performance and collaborate with stakeholders to resolve issues
Participate in system design discussions to ensure testability, regulatory compliance, and patient safety alignment
Quality, Compliance & Process Improvement
Ensure testing activities comply with GxP, ICH, and GCP requirements
Support audit readiness by maintaining high-quality documentation and traceability
Contribute to standardization of IRT testing approaches, templates, and best practices across studies
Support vendor evaluations and audits with a focus on testing adequacy and compliance
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline
Advanced degree preferred
Required Experience
5 to 7 years of experience in clinical supply operations, IRT systems, or global clinical trial delivery
Hands-on experience supporting IRT platforms across Phase I–IV clinical trials
Demonstrated expertise in clinical supply chain workflows and system testing
Core Skills & Competencies
Interactive Response Technology (IRT/IVRS/IWRS)
Clinical supply chain operations and logistics
Protocol interpretation and system requirements translation
GxP, GCP, and ICH regulatory compliance
Test case design, execution, and traceability
Strong analytical, documentation, and stakeholder communication skills
Preferred Skills
Experience developing IRT testing playbooks, templates, or standardized methodologies
Exposure to emerging IRT technologies and innovative testing approaches
Participation in IRT vendor selection, evaluation, or audit activities
Ability to train or mentor teams on IRT testing and defect management
Why Join This Role
This position offers an opportunity to work at the intersection of clinical operations, digital health technology, and patient safety. You will contribute directly to improving trial execution quality while expanding your expertise in global IRT and clinical supply systems within a regulated environment.
Keywords for SEO & Global Reach:
IRT Clinical Supply Specialist jobs, IRT Manager clinical trials, IWRS IVRS jobs India, clinical supply chain operations, IRT testing specialist, global clinical trials Hyderabad, GxP clinical systems roles
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