Manager, Interactive Response Technology (IRT) at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Ability to work independently and assume decision-making responsibilities on assigned projects
Experience managing IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning
Knowledge of BMS standards, quality principles, SOPs, and processes
Familiarity with regulatory requirements, including cGMP, 21 CFR Part 11, and ICH E6 (R2)
Capability to support UAT Services organization and ensure on-time delivery of user acceptance testing consistent with BMS SOPs
Skills in identifying areas of process improvement and leading improvement initiatives

Responsibilities

Lead successful execution and on-time delivery of IRT and support integrations with other clinical systems (e.g., Depots, Central Lab, EDC), ensuring fit-for-purpose systems per protocol and study parameters
Lead IRT projects as a strategic partner and single point of accountability for protocol assessments, requirements elicitation, system deployments, and resupply
Collaborate with IRT Leadership Team for standards adherence or non-standard requests
Bring issues of concern or system failures to the immediate attention of the IRT Leadership Team
Maintain vendor performance quality events in ADI log
Support IRT improvement initiatives and manage projects impacting daily operations for efficiency gains
Support key department and enterprise-level initiatives as IRT representative
Generate and oversee patient and container randomization schedules, ensuring alignment with protocol and drug supply requirements; distribute as appropriate
Participate in IRT vendor relationships and oversight to ensure delivery of systems and seamless services
Consult and ensure on-time delivery of user acceptance testing of IRT systems, fostering collaboration with IT QA
Ensure systems and documentation comply with regulatory requirements and BMS SOPs
Ensure effective system access and functionality across all countries and user locations
Ensure on-time development of IRT data transfers with vendors/third-party vendors
Act as primary contact during IRT Maintenance for cross-functional study teams and vendors; provide timely responses to randomization/IRT issues and resolve them
Support all unblinding activities
Ensure eTMF compliance at the study level per group and BMS guidance
Engage and support study and CSMT project teams as necessary
Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs

Skills

IRT

UAT

EDC

Change Management

Vendor Oversight

Process Improvement

System Integration

Requirements Elicitation

Data Provisioning

Project Management

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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