Senior Sample Management Specialist

Position Summary

• The Senior 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. Additionally the Senior Specialist is expected to work with internal leadership on alignment of resources initiatives KPIs and performance trends and tasks to ensure overall execution of company vision and directives.

Key Responsibilities

• Lead global sample tracking kit logistics and discrepancy resolution across multiple clinical studies by collaborating with cross-functional teams to ensure seamless sample lifecycle execution.
• Oversee kit preparation distribution and site coordination to ensure timely and compliant sample collection.
• Interpret study protocols and lab manuals to apply sample workflows.
• Serve as primary point of contact for clinical sites CROs and clients regarding sample documentation training and compliance.
• Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems.
• Lead study setup in LIMS including protocol configuration and sample workflow parameters.
• Support study monitoring and close-out activities including reconciliation and final disposition of samples. Manage sample inventory requests and coordinate data transfers to clinical repositories per study timelines.
• Monitor patient sample collection schedules and protocol-defined assessment windows to ensure timely and compliant sample receipt.
• Monitor and report KPIs related to sample quality turnaround times (TATs) and operational performance.
• 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.
• Contribute to SOP development process optimization and training of junior staff.
• Assist with setting up new studies by thoroughly understanding study design and sample management requirements from the protocol PSD and lab manual.
• 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 5-6 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).
• Experience with Power BI Power Query and/or Power Automate.
• Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems.
• Experience using Smartsheet for project tracking and collaboration.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law.

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