Analyst – Clinical Biosample Operations
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Work Mode: On-Site
Role Summary
The Analyst – Clinical Biosample Operations supports the operational implementation and execution of biosample strategies across clinical trials. This role works closely with Biosample Operations Leads and cross-functional study teams to ensure effective biosample collection, tracking, processing, storage, shipment, and biobanking activities in compliance with clinical trial requirements and regulatory standards.
The position requires strong operational coordination skills, understanding of clinical trial processes, attention to detail, and the ability to work effectively within global and matrix-based organizations.
Key Responsibilities
Clinical Biosample Operations Support
Support Biosample Operations Leads in the execution of biosample strategies across assigned clinical trials.
Assist in the operational planning and management of biosample collection, handling, shipment, and storage activities.
Ensure biosample-related activities are executed according to study protocols and timelines.
Coordinate with internal and external stakeholders to support smooth biosample operations throughout the clinical study lifecycle.
Biobanking & Sample Management
Support biobanking activities including:
Sample Tracking
Sample Inventory Management
Sample Storage Coordination
Sample Shipment Monitoring
Ensure accurate documentation and traceability of biosamples.
Assist in maintaining biosample records and databases in accordance with study and regulatory requirements.
Support reconciliation of sample inventories and shipment records.
Clinical Trial Operations Support
Collaborate with Clinical Operations teams to support study execution.
Ensure biosample processes align with clinical trial protocols and operational plans.
Assist in resolving operational issues related to sample collection, logistics, and processing.
Support study teams in maintaining compliance with biosample management requirements.
Compliance & Quality Management
Ensure biosample activities comply with:
ICH-GCP Guidelines
Clinical Trial Regulations
Internal Standard Operating Procedures (SOPs)
Study-Specific Requirements
Support quality reviews and documentation checks.
Identify and escalate potential compliance risks or operational challenges.
Maintain inspection-ready documentation related to biosample activities.
Data Management & Reporting
Maintain accurate records and tracking systems for biosample operations.
Prepare reports related to sample inventory, shipment status, and operational metrics.
Support data reconciliation and quality control activities.
Ensure data accuracy, completeness, and traceability.
Cross-Functional Collaboration
Collaborate with:
Clinical Operations Teams
Translational Medicine Teams
Laboratory Partners
Biobanking Vendors
External Service Providers
Participate in project meetings and operational discussions.
Support communication and coordination across international and matrix teams.
Continuous Improvement
Identify opportunities to improve biosample operational processes.
Contribute to process optimization initiatives and best practice implementation.
Support the development and maintenance of operational documentation and workflows.
Promote efficiency, quality, and compliance across biosample operations activities.
Required Qualifications
Education
One of the following qualifications:
Bachelor's Degree in:
Biology
Biotechnology
Pharmacy
Life Sciences
Related Scientific Discipline
OR
Master's Degree in:
Biology
Biotechnology
Pharmacy
Life Sciences
Related Scientific Discipline
Experience
Minimum 2 years of operational experience in one or more of the following areas:
Clinical Trials
Clinical Operations
Biosample Management
Biobanking Operations
Translational Medicine Support
Experience working within pharmaceutical, biotechnology, CRO, or clinical research environments.
Experience supporting global clinical studies is preferred.
Uttar Pradesh :
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