Job Title: Biospecimen Quality and Reconciliation Specialist
Company: Amgen
Location: Hyderabad, India
Job ID: R-238025
Work Location Type: On Site
Category: Research
Date Posted: Mar 05, 2026
Salary: ₹10,00,000 – ₹18,00,000 per year (Estimated)
Job Overview
The Biospecimen Quality and Reconciliation Specialist is responsible for ensuring data integrity and operational accuracy across biospecimen management systems in clinical research. This role focuses on cross-system reconciliation, discrepancy resolution, data validation, and quality control processes. The specialist works closely with internal teams and external vendors to maintain compliance with regulatory standards while ensuring the accuracy, traceability, and completeness of biospecimen data throughout the clinical trial lifecycle.
Key Responsibilities
Perform cross-system reconciliation to ensure consistency across biospecimen databases and tracking systems.
Manage discrepancy queues and resolve issues prior to shipment or downstream processes.
Validate automated and manual results imports, including second-person verification controls.
Verify data management interfaces before exporting results or transferring datasets.
Conduct final results completeness checks and generate reports for samples without results.
Support database lock reconciliation and prepare supporting documentation for evidence packages.
Maintain reporting cadence for sample data changes and review vendor issue logs.
Oversee governance for biospecimen disposition including withdrawals, consent restrictions, and compromised samples.
Conduct end-of-study operational checks and prepare archive-ready documentation.
Identify recurring discrepancy patterns and recommend corrective or preventive actions.
Required Skills and Competencies
Strong analytical skills for reconciliation and cross-system validation.
Ability to perform root cause analysis for discrepancies involving vendors, clinical sites, or systems.
Knowledge of database lock procedures and regulatory documentation standards in clinical research.
High attention to detail and strong investigative mindset.
Understanding of consent-based restrictions and biospecimen disposition workflows.
Ability to function independently as a quality control layer in complex operational environments.
Awareness of risks related to blinded data handling and final dataset transfers.
Commitment to audit readiness and regulatory compliance.
Qualifications
Master’s degree with 3+ years of experience in clinical trials or biospecimen operations, OR
Bachelor’s degree with 5+ years of experience in clinical trials or biospecimen management.
Prior experience in biospecimen operations, quality control, or reconciliation processes related to clinical trials is preferred.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Reasonable accommodations will be provided for individuals with disabilities throughout the application and interview process.
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