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Sample Management Specialist

3 weeks, 3 days ago
India
Full-time
Junior
Database Administrator
Database Administration
HIPAA
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 92

Description

  • Maintain global oversight of unresolved sample discrepancies for incoming and outgoing shipments and work with sample management teams to obtain clarification.
  • Communicate and execute resolution actions to close discrepancies in a timely manner and support customer and business turnaround targets.
  • Identify trends in sample discrepancies across internal teams, collection sites, and study requirements, and consult on potential process improvements.
  • Provide study close-out support by reviewing sample data, sample dispositions, and reconciliation queries.
  • Perform quality control verification of data entry to ensure alignment with study-specific operating procedures and source documents.
  • Identify and clarify data corrections resulting from misalignment with 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 protocol-defined assessment windows to ensure compliant and timely sample receipt.
  • Prepare and maintain operational reports such as sample 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 line with QMS standards.
  • Support ad hoc analysis requests and other duties as assigned.

Requirements

  • 2-3 years of relevant experience.
  • Understanding of drug, device, and/or biologic development processes.
  • Experience with clinical database management systems.
  • Strong knowledge of 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?

Apply directly on the company website

Apply Now

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