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Manager, Biospecimen Management

Bristol Myers Squibb
0-2 years
18-32 lakhs
Hyderabad
10 June 15, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Position Summary

The Biospecimen Manager is responsible for overseeing biospecimen management activities across multiple clinical trials. The role ensures proper collection, tracking, storage, shipment, reconciliation, and compliance of biological samples throughout the clinical study lifecycle.

This position acts as a key liaison between clinical teams, laboratories, vendors, and study stakeholders to ensure biospecimen operations are executed efficiently and in compliance with regulatory requirements.


Alternative Job Titles

  • Clinical Sample Manager

  • Biospecimen Operations Manager

  • Clinical Biospecimen Lead

  • Sample Management Lead

  • Biological Sample Operations Manager

  • Clinical Sample Operations Specialist

  • Biospecimen Program Manager

  • Biorepository Operations Manager


Key Responsibilities

Clinical Trial Biospecimen Management

  • Manage biospecimen activities across 5–12 clinical trials simultaneously.

  • Ensure proper collection, handling, shipment, storage, and tracking of biological samples.

  • Monitor biospecimen lifecycle from collection through final disposition.

Specimen Management Planning

  • Develop and maintain Specimen Management Plans (SMPs).

  • Identify operational risks and implement mitigation strategies.

  • Ensure sample management activities align with protocol requirements.

Protocol & Regulatory Support

  • Provide biospecimen expertise during protocol development.

  • Ensure operational feasibility and regulatory compliance of sample collection procedures.

  • Support inspection readiness and audit preparedness.

Sample Tracking & Reconciliation

  • Track sample inventory and status using internal and external systems.

  • Perform reconciliation of collected, shipped, stored, and analyzed samples.

  • Investigate and resolve discrepancies.

Vendor & Laboratory Management

  • Coordinate activities with central laboratories and external vendors.

  • Review and align:

    • Lab Manuals

    • Laboratory Specifications

    • Vendor Documentation

    • Sample Handling Procedures

  • Enter biospecimen requirements into contracting systems.

Stakeholder Communication

  • Provide regular updates to clinical study teams regarding:

    • Sample inventory

    • Storage locations

    • Timelines

    • Quality issues

  • Serve as the primary point of contact for biospecimen-related matters.

Quality & Compliance

  • Maintain study documentation in an inspection-ready state.

  • Participate in vendor audits.

  • Support CAPA (Corrective and Preventive Action) activities.

  • Ensure adherence to SOPs and regulatory requirements.

Training & Process Improvement

  • Mentor and train new team members.

  • Participate in workflow optimization initiatives.

  • Support implementation of innovative biospecimen technologies and processes.


Required Skills & Competencies

Technical Skills

  • Clinical Trial Operations

  • Biospecimen Management

  • Sample Tracking & Reconciliation

  • Laboratory Vendor Management

  • Quality Management Systems

  • Clinical Documentation

  • Data Management Systems

Soft Skills

  • Project Coordination

  • Stakeholder Management

  • Communication Skills

  • Problem Solving

  • Attention to Detail

  • Organizational Skills

  • Risk Management


Preferred Educational Background

  • Life Sciences

  • Biotechnology

  • Biochemistry

  • Microbiology

  • Pharmacy

  • Clinical Research

  • Biomedical Sciences


Industry Experience

Typically requires experience in:

  • Clinical Research

  • Clinical Operations

  • Laboratory Operations

  • Biospecimen Management

  • Pharmaceutical Industry

  • Biotechnology Industry

Potential Total Compensation

  • Fixed Salary

  • Annual Performance Bonus (10–20%)

  • Health Insurance

  • Provident Fund (PF)

  • Employee Stock/Long-Term Incentives (role dependent)

  • Learning & Development Programs

  • Hybrid Work Benefits


Work Model

Hybrid (Site-by-Design)

  • Minimum 50% onsite presence required.

  • Remaining work may be performed remotely according to company policy.


Ideal Candidate Profile

A clinical research professional with expertise in biospecimen management, sample logistics, laboratory/vendor coordination, and regulatory compliance, capable of managing multiple global clinical trials while ensuring sample integrity, inspection readiness, and operational excellence across the clinical development process.