Manager, Biospecimen Management
Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb
Requisition ID: R1600709
Employment Type: Full-time
Role Summary
The Manager, Biospecimen Management is responsible for overseeing biospecimen operations across multiple clinical trials. The role ensures proper collection, tracking, reconciliation, and quality management of biospecimens while maintaining regulatory compliance and inspection readiness.
This role involves coordination across clinical teams, vendors, and operational stakeholders to ensure biospecimen-related processes are executed accurately and efficiently.
Key Responsibilities
1. Biospecimen Study Oversight
Manage biospecimen activities across 5–12 clinical trials with minimal supervision
Develop and maintain Specimen Management Plans
Identify risks in biospecimen workflows and implement mitigation strategies
2. Protocol and Study Input
Provide input into clinical trial protocols to ensure operational feasibility
Ensure biospecimen requirements align with regulatory and study requirements
Contribute to sample handling and logistics planning
3. Tracking and Data Management
Track biospecimen collection, shipment, storage, and reconciliation
Use internal and external systems for biospecimen status monitoring
Ensure accuracy and completeness of biospecimen data across systems
4. Vendor and Cross-functional Coordination
Enter biospecimen requirements into contracting and tracking systems
Ensure vendor documents (lab manuals, lab specifications) align with protocols
Act as liaison between clinical teams and external laboratory vendors
Resolve operational biospecimen issues with minimal supervision
5. Quality, Compliance, and Inspection Readiness
Maintain study documentation in an inspection-ready state
Ensure adherence to SOPs and regulatory guidance
Participate in vendor audits and support CAPA (Corrective and Preventive Action) activities
6. Reporting and Communication
Provide regular biospecimen status updates to clinical teams
Report inventory levels, sample quality issues, and timelines
Communicate risks and operational challenges proactively
7. Training and Leadership
Provide training and mentorship to new team members
Support knowledge transfer and capability building within the team
Participate in cross-functional initiatives to improve processes and workflows
8. Process Improvement and Innovation
Contribute to cross-functional initiatives for workflow optimization
Support adoption of new technologies in biospecimen management
Identify opportunities for operational efficiency improvements
Qualifications and Experience
Education
Bachelor’s degree in life sciences, biotechnology, pharmacy, or related field
Experience
Experience in clinical trials, laboratory operations, or biospecimen/sample management
Exposure to clinical research environments preferred
Skills
Strong understanding of biospecimen lifecycle and clinical trial processes
Knowledge of regulatory requirements and GCP principles
Experience with clinical tracking systems and databases
Strong organizational and coordination skills
Ability to manage multiple trials simultaneously
Soft Skills
Strong communication and stakeholder management skills
Attention to detail and problem-solving ability
Ability to work independently with minimal supervision
Strong time management and prioritization skills
Role Nature
Operational and coordination-heavy clinical research role
Interfaces between clinical teams, labs, and vendors
Focus on compliance, logistics, and sample integrity
Moderate leadership component (training and mentorship)
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