Position Summary:
The Senior Specialist, Sample Management is responsible for leading complex biospecimen coordination activities across multiple clinical trials. This position oversees the full biospecimen lifecycle—including kit preparation, logistics, sample receipt, data transfer, and final disposition—ensuring alignment with study protocols and regulatory standards. The role requires strong project coordination skills, cross-functional collaboration, and a client-focused mindset to support diverse therapeutic programs and global stakeholders.
Essential functions of the job include but are not limited to:
- 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.
Qualifications:
Minimum Required:
- Bachelor’s degree in Life Sciences or related field required, with 5+ years of relevant experience; or Associate’s degree in Life Sciences or related field with 10+ years of relevant experience.
- Experience in biospecimen lifecycle management, clinical development, or clinical laboratory analysis.
- Proficiency in LIMS, biospecimen inventory systems, and data governance principles.
- Strong attention to detail, time management, and communication skills.
- Demonstrated ability to manage projects and meet deliverable timelines.
- Responsiveness and professionalism in client interactions.
- Proficiency in Microsoft Office tools (Excel, Word, Outlook, PowerPoint).
- Proven client service orientation and ability to build effective relationships with internal and external stakeholders.
- Experience with kitting logistics and coordination across clinical sites and vendors.
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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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