Sr Sample Management Specialist

Precision Medicine Group•Frederick, MD

4d•Hybrid

About The Position

This role is a hybrid position, requiring 3 days a week onsite, with two remote. The Senior Sample Management Specialist serves as the primary operational liaison between clients, Project Management, Biorepository, Logistics, Kitting and Site Services teams. This role is responsible for the coordination, monitoring, and delivery oversight of sample lifecycle activities, including site shipment tracking, accessioning, storage, inventory management, retrieval, shipment coordination, discrepancy resolution, and client reporting for sample management activities. The role ensures sample operational excellence, compliance, client satisfaction in support of global clinical trials and biorepository programs.

Requirements

Bachelor’s degree in Life Sciences, Biomedical Sciences, or related field (required).
Minimum of 5 years of experience in biospecimen operations, clinical research, or laboratory management.
Strong understanding of regulatory requirements and biospecimen handling standards.
Proven ability to work in a cross-functional and client delivery environments.
Excellent organizational, communication, and problem-solving skills.
Intermediate knowledge of data integrity principles and data governance strategies.
Intermediate experience with biospecimen inventory systems and reporting capabilities.
Proven time management skills and a strong attention to detail.
Able to demonstrate high-performance standards, ability to manage multiple task deadlines, and proactively communicate anticipated deviations from expected timelines and/or deliverables.
Previous experience complying with internal QMS requirements.
Intermediate computer skills that include experience with relevant software applications, including Microsoft 365/MS Office.
Analyze data and procedures, identify issues, and solve problems using critical thinking skills.
Communicate effectively, both orally and in writing, with technical and non-technical customers and colleagues.
Read and interpret documents (i.e. operating instructions and business processes).
Work independently and collaboratively with minimal supervision.
Adapt to shifting priorities and varied responsibilities while maintaining efficiency and professionalism.
Maintain a high standard of courtesy and cooperation with co-workers and customers.
Strong verbal and written communication skills and ability to read, write, speak fluently, and comprehend the English language.

Nice To Haves

Experience with LIMS, biorepository systems, and data integration platforms is a plus.

Responsibilities

Serve as the primary point of contact for assigned client projects for all activities related to sample management.
Attend project kickoff, operational delivery and client project governance meetings.
Develop project specific sample logistics plans and monitor end-to-end sample activities for each study - site activation and kit supply, patient visit, sample collection, courier pickup & transit monitoring, sample receipt & accessioning, discrepancy management, inventory reconciliation, sample pulls for testing/destruction/shipments.
Assist the Project Manager with site training as needed.
Review and approve sample movement requests.
Support review of project scope changes and billable activities related to sample management activities.
Coordinate sample transfers between facilities and external laboratories.
Support domestic and international shipments in coordination with couriers, third-party labs and Logistics teams.
Ensure compliance with client-specific shipping requirements.
Track outbound and inbound shipments.
Monitor shipment delays and escalate issues to the logistics team, as needed.
Ensure sample inventories remain accurate and compliant with client requirements.
Coordinate inventory/database reconciliations and updates with Sample Data Management team.
Support sample discrepancy investigations and coordinate site outreach activities with Site Services team.
Monitor discrepancy aging and resolution metrics.
Prepare discrepancy trend reports and corrective action recommendations with the Project Manager.
Generate and present operational metrics to clients and leadership.
Utilize reporting tools such as Power BI, Excel, and ERP systems.
Support dashboard development and KPI reporting initiatives.
Ensure compliance with SOPs, GxP standards, and client requirements.
Support audits and inspections.
Document deviations and corrective actions.
Participate in continuous process improvement initiatives.