Biospecimen Data Operations Specialist
Company: Amgen
Location: Hyderabad, Telangana, India
Job Type: Full-Time | On-Site
Experience: 3 – 6+ Years (Clinical Trials / Biospecimen Operations / LIMS Systems)
Qualification: Bachelor’s or Master’s in Life Sciences, Biotechnology, Clinical Research, or related field
Approx Salary: ₹10 LPA – ₹20 LPA
Job Overview
Amgen is hiring a Biospecimen Data Operations Specialist to manage biospecimen data systems, study configurations, and laboratory data workflows within clinical trials.
This role focuses on LIMS configuration, specimen logistics, data integration, and operational oversight to ensure accurate biospecimen tracking, compliant sample handling, and smooth data transfers across clinical research systems.
The position collaborates closely with clinical operations teams, laboratories, data management teams, and external biorepositories.
Key Responsibilities
1. LIMS Configuration & Study Setup
Configure clinical studies in Laboratory Information Management Systems (LIMS) including:
Product and test categories
Cohorts and schedules
Test plans and study parameters
Ensure alignment with clinical protocols and dosing schemas.
Implement safeguards for blinded clinical trial data.
2. Clinical Data Integration
Configure clinical data management interfaces and mapping templates.
Ensure accurate data mapping, transfer readiness, and interface integrity.
Manage TrialBridge data imports and discrepancy review processes.
3. Biospecimen Logistics & Tracking
Monitor inventory files and external biorepository integrations.
Validate sample shipment registrations and specimen tracking.
Ensure shipment readiness and compliance with quality standards.
4. Operational Workflow Management
Manage work orders and test orders for laboratory testing workflows.
Maintain export templates and operational governance processes.
Support BSM plan generation and version control.
5. Study Lifecycle Management
Manage study status transitions including approval, activation, and completion.
Perform end-of-study system closure and documentation verification.
Maintain complete study documentation including data flow maps and operational logs.
Required Skills
Technical Skills
Advanced experience with Laboratory Information Management Systems (LIMS)
Knowledge of biospecimen logistics and laboratory assay workflows
Experience with data import/export systems and mapping templates
Operational Skills
Strong documentation and audit trail management
Troubleshooting of data imports, shipments, and system transfers
Understanding of blinded data controls in clinical trials
Preferred Qualifications
Experience working with clinical research laboratories or biorepositories
Knowledge of clinical data management systems and sample tracking platforms
Experience supporting multi-study clinical trial operations
Key Competencies
Biospecimen data management in clinical trials
LIMS configuration and system integration
Clinical data workflows and interface management
Operational oversight of specimen logistics
Quality compliance and documentation management
About the Company
Amgen is a leading global biotechnology company committed to discovering and delivering innovative medicines for serious diseases. Through cutting-edge research and advanced technologies, Amgen continues to improve patient outcomes and transform healthcare worldwide.
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