IRT Clinical Supplies Manager - Operations

IRT Clinical Supplies Manager

Location : Hybrid – Hyderabad or Noida

About Signant Health

At Signant Health, we are on a mission to help bring life-changing treatments to patients faster. As a global leader in clinical trial technology and services, we operate at the intersection of science and innovation—partnering with biopharmaceutical companies to simplify trial execution and enhance the patient experience. With a collaborative culture, cutting-edge digital solutions, and a focus on real-world impact, Signant is where your work drives meaningful change in global healthcare.

ROLE PURPOSE

The IRT Clinical Supplies Manager is responsible for developing comprehensive test cases and testing strategies for Interactive Response Technology (IRT) systems used in Phase I–IV clinical studies. As a critical component in safeguarding patients receiving investigational medicinal products (IMP), the IRT system must function accurately according to protocol requirements and supply chain strategies. Leveraging expertise in both IRT functionality and clinical supply operations, this role translates clinical trial protocols and supply chain plans into detailed test scenarios that validate system performance, ensuring proper management of product allocation, randomization, blinding, resupply triggers, and distribution logistics in compliance with GxP regulations and patient safety standards.

KEY ACCOUNTABILITES

• Analyze clinical study protocols to identify IRT-relevant requirements, including randomization schemes, blinding, treatment allocation, dosing regimens, and visit schedules.
• Translate protocol and supply chain requirements into technical specifications that can be systematically tested.
• Develop comprehensive test cases covering positive, negative, edge, and boundary scenarios for IRT system configurations.
• Validate supply chain strategies through test cases for depot management, site resupply triggers, expiry management, temperature excursions, and return / destruction workflows.
• Documented system behaviors and acceptance criteria to ensure clear pass / fail determination for all test cases.
• Maintain a test case library and traceability matrix linking test cases to protocol requirements and system specifications.
• Create realistic test data sets and patient scenarios that reflect clinical trial complexities.
• Identify and escalate protocol ambiguities or gaps that could impact IRT functionality, collaborating with study teams for resolution.
• Serve as the primary liaison between stakeholders and IRT development teams, ensuring clear communication of requirements and acceptance criteria.
• Participate in system design discussions to ensure testability and compliance with GxP and patient safety standards.

DECISION MAKING & INFLUENCE

Essential

KNOWLEDGE, SKILLS, AND ATTRIBUTES

Desirable :

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.

Skills Required

Depot Management