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Biospecimen Quality and Reconciliation Specialist

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Amgen

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Location:
India , Hyderabad

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Contract Type:
Not provided

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Salary:

Not provided

Job Responsibility:

  • Accountable for cross-system reconciliation
  • Accountable for discrepancy queue management and pre-shipment resolution
  • Accountable for validation of results imports (automated and manual) including second-person verification controls
  • Accountable for data management interface validation prior to exports
  • Accountable for final results completeness verification and samples-not-resulted reporting
  • Accountable for database lock reconciliation and evidence package preparation
  • Accountable for Sample Data Change reporting cadence and Vendor Issue Log review
  • Accountable for disposition governance (withdrawals, consent not obtained, compromised samples)
  • Accountable for end-of-study operational checks and archive-ready documentation
  • Accountable for identifying systemic discrepancy trends and recommending corrective actions

Requirements:

  • Master’s degree & 3 years of experience with a strong Knowledge of clinical trials
  • Bachelor’s degree & 5 years of experience with a strong Knowledge of clinical trials
  • Prior experience in biospecimen operations and management in relation to clinical trials
  • Strong reconciliation and cross-system validation logic
  • Root cause analysis capability across vendor, site, and system issues
  • Knowledge of data base lock processes and regulatory documentation standards
  • High-detail orientation with investigative rigor
  • Understanding of consent-based restrictions and disposition workflows
  • Ability to operate independently as quality control layer
  • Risk sensitivity regarding blinded data and final transfer integrity
  • Audit defensibility mindset

Additional Information:

Job Posted:
March 19, 2026

Work Type:
On-site work
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