Sample Management Specialist

Position Summary

• The Specialist Sample Management is responsible for the support coordination and training of Sample Management activities and initiatives focused on discrepancy tracking and resolution (including customer/site outreach) database troubleshooting and modifications stemming from internal requests and external data reconciliations and quality control review of data entered to ensure compliance with operating procedures and study-specific data entry requirements.

Key Responsibilities

• Maintain global oversight of unresolved discrepancies identified by internal sample management teams for both incoming and outgoing shipments. Work directly with sample management teams to receive any additional clarification or justification as needed.
• Communicate and/or execute appropriate resolution actions to close discrepancies in a timely manner to meet customer and business deliverables on TAT and OTIF.
• Identify and consult on trends related to sample discrepancies observed with internal teams collection sites and/or established data entry/study requirements
• Provide necessary study close-out support for sample management including internal assessment of data sample dispositions and resolve any reconciliation queries and actions.
• Perform quality control (QC) verification of data entry performed by global sample management teams to ensure compliance/alignment to data entry requirements in accordance with project-specific operating procedures and incoming source documents
• Identify and clarify as needed data corrections stemming from misalignments observed from prescribed data entry requirements
• Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems.
• Study setup in LIMS including protocol configuration and sample workflow parameters.
• Monitor patient sample collection schedules and protocol-defined assessment windows to ensure timely and compliant sample receipt.
• Prepare and maintain operational reports including sample inventory kit tracking and site performance metrics.
• Participate in root cause analysis and corrective actions for sample-related quality events.
• Assist with documentation of sample related issues corrections and compliance with QMS standards.
• Support ad hoc requests for analysis and other duties as assigned.

Department: Data Operations / Biorepository Support

Qualifications

Minimum Requirements

• Minimum of 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 (Word Excel PowerPoint Outlook).
• Excellent organizational written and verbal communication skills in English.

Preferred Qualifications

• Bachelors / masters degree in a life science related field
• Background in clinical scientific or healthcare disciplines.
• Familiarity with data privacy regulations (e.g. GDPR HIPAA).
• Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems.

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