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Sample Management Specialist

5 days, 19 hours ago
India
Full-time
Junior
Operations Specialist
Database Administration
HIPAA
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 109

Description

  • Maintain global oversight of unresolved sample discrepancies for incoming and outgoing shipments and coordinate with sample management teams to clarify issues.
  • Communicate and execute resolution actions to close discrepancies in line with turnaround time and on-time, in-full deliverables.
  • Identify trends in sample discrepancies and consult with internal teams, collection sites, and study requirements to address recurring issues.
  • Provide study close-out support by reviewing data, sample dispositions, reconciliation queries, and related actions.
  • Perform quality control review of data entry to ensure compliance with operating procedures, source documents, and study-specific requirements.
  • Identify and clarify data corrections arising from misalignments in prescribed data entry requirements.
  • Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems.
  • Set up studies in LIMS, including protocol configuration and sample workflow parameters.
  • Monitor patient sample collection schedules and assessment windows to ensure timely and compliant sample receipt.
  • Prepare and maintain operational reports, including inventory, kit tracking, and site performance metrics.
  • Participate in root cause analysis and corrective actions for sample-related quality events.
  • Document sample-related issues, corrections, and compliance activities in alignment with QMS standards.

Requirements

  • 2-3 years of relevant experience.
  • Comprehensive understanding of drug, device, and/or biologic development processes.
  • Experience with clinical database management systems.
  • Strong expertise in data quality standards and practices.
  • Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
  • Excellent organizational, written, and verbal communication skills in English.
  • Bachelor’s or master’s degree in a life science-related field preferred.
  • Background in clinical, scientific, or healthcare disciplines preferred.
  • Familiarity with data privacy regulations such as GDPR and HIPAA preferred.
  • Knowledge of Laboratory Information Management Systems (LIMS) and biospecimen inventory systems preferred.

Interested in this position?

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