IRT Clinical Supply Specialist

JOB TITLE: IRT Clinical Supplies Manager

REPORTS TO TITLE: Associate Director or Manager, Delivery Management, Global Technical Delivery

BUSINESS FUNCTION/ SUB-FUNCTION: GTD Technical Delivery

LOCATION: APAC Region

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 (maximum 10)

1. Analyze clinical study protocols to identify IRT-relevant requirements, including randomization schemes, blinding, treatment allocation, dosing regimens, and visit schedules.

2. Translate protocol and supply chain requirements into technical specifications that can be systematically tested.

3. Develop comprehensive test cases covering positive, negative, edge, and boundary scenarios for IRT system configurations.

4. Validate supply chain strategies through test cases for depot management, site resupply triggers, expiry management, temperature excursions, and return/destruction workflows.

5. Documented system behaviors and acceptance criteria to ensure clear pass/fail determination for all test cases.

6. Maintain a test case library and traceability matrix linking test cases to protocol requirements and system specifications.

7. Create realistic test data sets and patient scenarios that reflect clinical trial complexities.

8. Identify and escalate protocol ambiguities or gaps that could impact IRT functionality, collaborating with study teams for resolution.

9. Serve as the primary liaison between stakeholders and IRT development teams, ensuring clear communication of requirements and acceptance criteria.

10. Participate in system design discussions to ensure testability and compliance with GxP and patient safety standards.

DECISION MAKING & INFLUENCE

1. Identifies opportunities to standardize test case templates and testing approaches across studies

2. Contributes to development of IRT testing playbooks and best practices

3. Proposes process improvements to enhance testing efficiency and coverage

4. Participates in vendor selection activities by evaluating IRT vendor testing capabilities and tools

5. Serves as subject matter expert for IRT testing questions from internal and external stakeholders

6. Participates in audits of IRT vendors with focus on testing adequacy

KNOWLEDGE, SKILLS, AND ATTRIBUTES

Essential (maximum 10)

1. Bachelor's degree in Life Sciences, Pharmacy, Clinical Research, or related field (higher degree preferred).

2. 5–7 years of experience in clinical supplies management or related area, including IRT systems and global clinical trial operations.

3. Extensive experience with Interactive Response Technology (IRT) systems in clinical trial settings (Phase I–IV).

4. Strong understanding of clinical trial protocols, including randomization, blinding, dosing regimens, and visit schedules.

5. Proven ability to develop and execute comprehensive test cases for complex clinical and supply chain scenarios.

6. In-depth knowledge of GxP, ICH, and GCP guidelines and their application in system testing.

7. Experience in clinical supply chain operations, including depot management, resupply triggers, expiry management, and distribution workflows.

8. Ability to translate protocol and supply chain requirements into technical specifications for systematic testing.

9. Strong analytical and problem-solving skills to identify ambiguities and propose solutions.

10. Excellent stakeholder management and communication skills, including experience liaising with vendors and cross-functional teams.

11. Proficiency in documentation standards to support audits, regulatory inspections, and traceability requirements.

Desirable (maximum 5)

1. Experience contributing to development of IRT testing playbooks, templates, or best practices.

2. Proven ability to identify and implement process improvements to enhance testing efficiency and coverage.

3. Knowledge of emerging IRT technologies and industry trends, including innovative testing methodologies.

4. Experience participating in vendor selection and audits, influencing decisions on testing adequacy and compliance.

5. Ability to train and mentor study teams on test case execution and defect documentation.

ROLE DIMENSIONS

Direct Reports: 0

Indirect Reports: 0

Travel: Up to 15% International Travel

Budget Responsibility: N/A