Position Summary

The Sample Management Operations Manager provides leadership, operational oversight, and technical expertise for the Sample Management function, ensuring the integrity, efficiency, scalability, and compliance of specimen management operations supporting laboratory, research, and organizational initiatives. This position serves as both a people leader and working manager, actively supporting day-to-day specimen management activities while leading the continued evolution of the Sample Management operation.

The Manager is responsible for overseeing the complete lifecycle management of remnant biological specimens following diagnostic testing, including specimen receipt, inventory management, storage, retrieval, request fulfillment, de-identification, distribution, disposition, and chain of custody. Leveraging previous experience in specimen management operations, this role identifies opportunities to strengthen workflows, optimize Laboratory Information Management System (LIMS) utilization, implement industry best practices, and improve operational efficiency to support organizational growth.

Working collaboratively with Laboratory Operations, Clinical Operations, Research, Quality, Information Technology, and other cross-functional stakeholders, the Manager develops a high-performing team, drives continuous improvement initiatives, and helps build a scalable, customer-focused Sample Management operation while ensuring compliance with applicable regulatory and organizational requirements.

Job Responsibilities

• Leadership & Team Development. Lead, coach, and develop the Sample Management team by providing day-to-day leadership, technical guidance, performance management, and professional development while fostering a culture of accountability, collaboration, customer service, quality, and continuous improvement.
• Sample Management Operations. Provide operational oversight of the complete lifecycle management of remnant biological specimens following diagnostic testing, including specimen receipt, inventory management, storage, retrieval, request fulfillment, transfer, distribution, de-identification, and disposition. Serve as a working manager by supporting complex specimen management activities, resolving escalated operational issues, and ensuring specimen integrity and chain of custody throughout the specimen lifecycle.
• Inventory, Logistics & Resource Management. Oversee specimen inventory, storage capacity, environmental monitoring, logistics, retrieval, transfers, and distribution while ensuring inventory accuracy, efficient utilization of resources, and operational readiness to support current and future business needs.
• Data Management & Technology Optimization. Ensure the integrity of specimen data within Laboratory Information Management Systems (LIMS) and Sample Management Systems while driving optimization of workflows, reporting, inventory visibility, system utilization, and operational technologies to improve efficiency and scalability.
• Quality Assurance & Regulatory Compliance. Lead quality assurance activities by ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), CLIA, CAP, FDA, HIPAA, and other applicable regulatory requirements through documentation oversight, audits, inventory reconciliation, corrective actions, and continuous monitoring.
• Operational Excellence & Subject Matter Expertise. Serve as the operational subject matter expert for Sample Management by leveraging industry experience to implement best practices, improve workflows, standardize processes, optimize specimen utilization, and support the continued evolution and scalability of the Sample Management function.
• Cross-Functional Leadership & Customer Service. Partner with Laboratory Operations, Clinical Operations, Research, Quality, Information Technology, Procurement, and other stakeholders to coordinate specimen management activities, resolve operational challenges, communicate specimen status, and deliver exceptional customer service while supporting organizational initiatives.
• Performance Monitoring & Continuous Improvement. Establish and monitor operational metrics, service levels, inventory trends, turnaround times, and quality indicators to evaluate departmental performance, identify opportunities for improvement, and drive operational excellence.
• Financial & Operational Planning. Support departmental budgeting, laboratory supply management, vendor relationships, staffing, workload forecasting, storage capacity planning, and resource allocation to ensure efficient and sustainable specimen management operations.
• Communication. Communicate effectively with leadership, team members, and cross-functional stakeholders regarding operational priorities, specimen management activities, process improvements, and departmental performance while promoting transparency, collaboration, and engagement.

Required Qualifications

• Bachelor's degree in Biological Sciences, Laboratory Science, Healthcare Administration, or a related scientific discipline. Equivalent education and relevant experience may be considered.
• Minimum of five years of progressive relevant experience within a laboratory, pathology, clinical research, biorepository, or related scientific environment.
• Minimum of two years of leadership or supervisory experience leading operational teams.
• Demonstrated expertise in specimen lifecycle management, including specimen inventory management, chain of custody, request fulfillment, de-identification, specimen tracking, storage operations, and data management.
• Experience utilizing Laboratory Information Management Systems (LIMS) and/or Sample Management Systems to support specimen operations.
• Demonstrated experience improving operational workflows, implementing best practices, optimizing system utilization, and supporting organizational growth.
• Strong knowledge of applicable regulatory requirements governing specimen management, including CLIA, CAP, FDA, HIPAA, and Good Clinical Practice (GCP).
• Excellent leadership, organizational, communication, analytical, and problem-solving skills.
• Demonstrated ability to manage multiple priorities while leading teams in a dynamic operational environment.
• Ability to work on-site to support specimen management operations and provide direct operational leadership.

Preferred Qualifications

• Master's degree in Biological Sciences, Healthcare Administration, Business Administration, or a related discipline.
• Previous leadership experience supporting specimen management, pathology operations, biorepository operations, clinical research, or precision medicine programs.
• Experience leading operational change initiatives, workflow redesign, or implementation of specimen management technologies.
• Experience with process improvement methodologies such as Lean, Six Sigma, or equivalent operational excellence programs.
• Project management certification or demonstrated project leadership experience.
• Laboratory Information Management System (LIMS) implementation or optimization experience.
• Good Clinical Practice (GCP), Human Subject Protection, and IATA training.
• Customer service experience supporting laboratory or research operations.

Physical Demands

• Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time.
• Ability to lift up to 30 lbs.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires some evenings, weekends and/or holidays.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.