Manager – Interactive Response Technology (IRT)
Company: Bristol Myers Squibb (BMS)
Location: Hyderabad, Telangana, India
Job ID: R1591741
Employment Type: Full-time
Role Overview
The Manager – Interactive Response Technology (IRT) is responsible for managing end-to-end IRT systems across multiple clinical trials. This includes system development, vendor oversight, integration with clinical systems, user acceptance testing (UAT), and lifecycle maintenance.
The role ensures that IRT systems support clinical trial execution accurately, compliantly, and in alignment with protocol requirements and global regulatory standards.
Key Responsibilities
1. IRT System Management
Lead execution and delivery of IRT systems for multiple clinical studies.
Ensure systems are aligned with protocol requirements and operational study needs.
Oversee system configuration including:
Randomization
Drug supply management
Blinding and unblinding processes
2. Study Support & Clinical Integration
Support integration of IRT with:
EDC systems
Central labs
Depots and supply systems
Act as single point of accountability for assigned studies.
Provide ongoing support throughout study lifecycle and maintenance phase.
3. Vendor Management
Manage relationships with IRT vendors and third-party providers.
Ensure timely delivery of system build, updates, and data transfers.
Track vendor performance and maintain issue logs (ADI log).
4. User Acceptance Testing (UAT)
Oversee UAT activities in compliance with SOPs.
Collaborate with IT QA teams to ensure system validation.
Ensure timely completion of testing and deployment activities.
5. Compliance & Quality Assurance
Ensure systems comply with:
GCP (ICH E6 R2)
GMP
21 CFR Part 11
BMS SOPs and regulatory standards
Maintain audit readiness and documentation compliance (eTMF).
6. Clinical Supply & Randomization Oversight
Generate and manage patient and container randomization schedules.
Ensure alignment with protocol and drug supply requirements.
Support clinical supply operations and logistics coordination.
7. Issue Management & Troubleshooting
Act as primary contact for IRT-related issues during study lifecycle.
Resolve system, integration, and data-related problems promptly.
Escalate critical issues to leadership when required.
8. Process Improvement
Identify and support process improvement initiatives.
Contribute to operational efficiency enhancements in IRT systems.
Participate in enterprise-level transformation projects.
9. Cross-Functional Collaboration
Work closely with:
Clinical study teams
Clinical supply operations
IT and QA teams
External vendors
Support global teams in a matrix environment.
Required Qualifications
Education
Bachelor’s degree required
Experience
Minimum 5+ years of experience in:
Clinical research
Pharmaceutical or healthcare systems (preferred)
IRT or similar clinical systems environment
Technical Knowledge
Strong understanding of:
Interactive Response Technology (IRT)
Clinical Trial Management Systems (CTMS)
Clinical supply chain operations
Randomization and blinding concepts
Data integrity and system validation
Compliance Knowledge
Experience working in regulated environments:
GCP (Good Clinical Practice)
GMP (Good Manufacturing Practice)
21 CFR Part 11 compliance
Exposure to regulatory audits
Tools & Systems
Microsoft Office Suite (required)
MS Project / MS Visio (preferred)
Requirements and workflow visualization tools
Skills & Competencies
Strong analytical and problem-solving skills
Excellent communication and stakeholder management
Ability to work in global, cross-functional teams
Strong attention to detail and operational discipline
Ability to manage multiple studies simultaneously
Work Environment
Global clinical trial operations environment
High compliance and regulated system environment
Cross-functional coordination across clinical, IT, QA, and vendors
On-site / hybrid depending on assignment
Core Purpose
To ensure seamless, compliant, and efficient execution of Interactive Response Technology systems that support accurate clinical trial operations and patient safety across global studies.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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China | Quarry Bay |Liaoning :
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