Manager, Interactive Response Technology (IRT)
Category: Clinical Operations / Clinical Technology
Location: Hyderabad, India
Employment Type: Full-Time
Company: Bristol Myers Squibb
Position Summary
The Manager, Interactive Response Technology (IRT) is responsible for managing IRT systems across multiple clinical studies, including system development, vendor oversight, change management, randomization management, data integrations, and system maintenance.
This role serves as the primary IRT lead for study teams, ensuring successful deployment, validation, compliance, and ongoing support of IRT solutions while collaborating with Clinical Operations, Clinical Supplies, Data Management, Central Labs, EDC teams, and external vendors.
The position also drives process improvements, supports User Acceptance Testing (UAT), and ensures adherence to regulatory and quality standards.
Key Responsibilities
IRT Strategy & Study Management
Lead end-to-end IRT delivery for multiple global clinical trials.
Act as the primary point of accountability for assigned IRT projects.
Conduct protocol assessments and requirement gathering.
Ensure IRT systems align with study design, protocol requirements, and operational needs.
Support study teams throughout the IRT lifecycle.
IRT System Development & Deployment
Oversee IRT system design, configuration, testing, deployment, and maintenance.
Ensure fit-for-purpose system functionality.
Support system integrations with:
Electronic Data Capture (EDC)
Central Laboratories
Clinical Supply Systems
Depot Management Systems
Third-Party Vendors
Vendor Oversight & Relationship Management
Manage relationships with IRT vendors and service providers.
Monitor vendor performance and service quality.
Maintain vendor quality event documentation.
Escalate system issues and vendor concerns appropriately.
Foster strong collaboration between internal teams and external vendors.
Randomization & Drug Supply Management
Generate and oversee:
Patient Randomization Schedules
Container Randomization Schedules
Ensure randomization strategies comply with protocol requirements.
Coordinate schedule distribution with:
Clinical Supply Operations
IRT Vendors
Study Teams
User Acceptance Testing (UAT)
Lead and coordinate UAT activities.
Ensure testing complies with SOPs and validation requirements.
Partner with IT Quality Assurance teams.
Review and approve testing documentation.
Ensure system readiness before production release.
Data Integration & Data Provisioning
Oversee development and maintenance of IRT data transfers.
Ensure seamless exchange of data between:
IRT Systems
EDC Platforms
Supply Chain Systems
Central Laboratories
Third-Party Vendors
Ensure accurate and timely data delivery.
IRT Maintenance & Operational Support
Serve as primary contact during study conduct.
Troubleshoot randomization and system-related issues.
Manage system changes and updates.
Ensure timely issue resolution throughout study execution.
Support emergency and planned unblinding activities.
Compliance & Quality Management
Ensure compliance with:
cGMP
21 CFR Part 11
ICH E6 (R2)
Internal SOPs
Regulatory requirements
Maintain inspection-ready documentation.
Ensure audit and regulatory readiness.
eTMF & Documentation Management
Ensure study-level eTMF compliance.
Maintain IRT-related documentation.
Support document filing according to company standards.
Ensure complete audit trails and validation records.
Process Improvement & Leadership
Identify operational inefficiencies.
Lead IRT process improvement initiatives.
Support enterprise-wide projects involving clinical technology.
Serve as IRT subject matter expert for cross-functional teams.
Education Requirements
Required
Bachelor's Degree
Preferred
Degree in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Health Sciences
Information Technology
Biomedical Sciences
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