Maajid Basha Court

Project Manager @SDC (Statistics & Data Corporation)

Hyderabad, IN

Study Planning & Setup• Collaborate with Sponsors, Clinical Teams, and IT to gather IRT system requirements.• Define randomization strategies (e.g, stratified, block, minimization).• Oversee drug supply management configurations (e.g, depot/site shipments, resupply triggers).• Ensure IRT design aligns with protocol requirements and regulatory standards (FDA, EMA, ICH-GCP).2. System Development & Validation• Work with IRT vendors to configure the system (e.g, Medidata Balance, Almac, Suvoda, 4G Clinical).• Lead User Acceptance Testing (UAT) and System Integration Testing (SIT) with cross-functional teams.• Validate system functionalities (e.g, kit assignment, shipment tracking, temperature excursions).Maintain 21 CFR Part 11 compliance and ensure proper audit trails.3. Study Execution & Maintenance• Act as the IRT primary contact for study teams and sites.• Monitor randomization and drug supply trends, ensuring smooth inventory management.• Troubleshoot and resolve IRT system issues during study conduct.• Implement mid-study changes (e.g, protocol amendments, site additions, threshold adjustments).• Provide IRT training to study teams, sites, and clinical operations.4. Stakeholder Communication & Support• Liaise between Sponsors, Clinical Operations, Data Management, and IT.• Attend study governance meetings and provide IRT status updates.• Ensure alignment of IRT functionalities with EDC, CTMS, and Supply Chain Systems.• Support investigational sites with IRT troubleshooting and best practices.5. Study Closeout & Reporting• Oversee IRT database lock and ensure all records are archived properly.• Generate final drug accountability reports and randomization logs for submission.• Support regulatory audits and inspections related to IRT system compliance.

Jawaharlal Nehru Technological University

BTECH, Information Technology