Company: Bristol Myers Squibb
Location: Hyderabad, Telangana, India
Job Type: Full-time
Requisition ID: R1600709
Position Overview
The Manager, Biospecimen Management is responsible for overseeing biospecimen operations across multiple clinical trials. The role ensures compliant, timely, and high-quality handling of biospecimens while coordinating between clinical teams, vendors, and laboratories. The position operates with minimal supervision and includes both operational oversight and cross-functional collaboration.
Core Responsibilities
Clinical Trial Biospecimen Oversight
Manage biospecimen operations across approximately 5–12 clinical trials.
Develop and maintain the Specimen Management Plan, including risk identification and mitigation strategies.
Provide biospecimen input during protocol development to ensure operational feasibility and regulatory compliance.
Sample Tracking and Compliance
Track, reconcile, and maintain biospecimen status using internal and external systems.
Ensure accurate entry of biospecimen requirements into contracting systems.
Align vendor documentation (e.g., lab manuals, lab specifications) with protocol and specimen management plans.
Maintain inspection-ready documentation for all assigned studies.
Stakeholder and Vendor Coordination
Serve as liaison between clinical teams and external vendors to resolve biospecimen-related issues.
Provide regular status updates to clinical teams, including inventory, quality, and timeline reporting.
Participate in vendor audits and support Corrective and Preventive Action (CAPA) processes.
Process, Quality, and Training
Ensure adherence to SOPs, regulatory requirements, and internal guidance documents.
Contribute to workflow optimization and adoption of innovative technologies.
Provide training and mentorship to junior team members or new hires.
Qualifications
Education
Bachelor’s degree in life sciences or related field preferred.
Experience
Experience in biospecimen management or clinical operations (mid-level professional experience expected).
Exposure to clinical trial environments and regulated processes.
Skills and Competencies
Strong understanding of biospecimen workflows in clinical research.
Ability to manage multiple studies and priorities simultaneously.
Knowledge of clinical trial documentation and regulatory expectations.
Strong communication and stakeholder management skills.
Ability to work independently with minimal supervision.
Experience with vendor management and cross-functional coordination.
Additional Notes
Role involves participation in audits and regulatory readiness activities.
Requires ability to manage operational complexity across multiple studies.
Emphasis on compliance, quality control, and process improvement.
Uttar Pradesh :
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