Biospecimen Project Manager

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Oversee the entire biospecimen lifecycle, from sample receipt to analysis and final disposition.

• Ensure the accuracy of specimen metadata.

• Transfer analytical data to the clinical repository.

• Enhance the efficiency of specimen management through sharing knowledge and best practices.

• Participate in or take the lead on special projects.

• Comply with client policies and Standard Operating Procedures.

• Review study protocols and service-provider scope-of-work documents for details on sample handling and processing.

• Set up studies and electronic protocols within the LIMS.

• Develop and manage project plans.

• Coordinate data transfer plans with analytical laboratories.

• Address and resolve discrepancies in specimen metadata.

• Submit specimens for analytical assays in accordance with study timelines.

• Provide updates on specimens to study teams.

• Review the status of specimen receipts and data completeness; generate reports for study teams as needed.

• Facilitate database locks by confirming that specimens have final results and that data transfers are complete.

• Create reports for data management as required.

• Engage in or lead process-improvement initiatives.

• Assist with annual and long-term planning projections.

⛳️ Requirements

• Familiarity with transaction-based inventory and data management systems.

• Knowledge of clinical trial processes.

• Understanding of ICH, GCP, GLP, and local regulations.

• Proficiency in Excel, including the ability to build macros and templates.

• Strong skills in planning, organization, and time management.

• Experience with StarLIMS or another LIMS for managing biospecimens.

• A B.A./B.S. in life sciences, medical technology, or a related field.

• A minimum of 3–5 years of directly relevant experience.

• Experience in life sciences or medically related fields, including clinical development, biospecimen lifecycle management, or clinical laboratory analysis.

• Exceptional attention to detail and strong multitasking abilities.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health benefits package.

• Opportunities for professional development and advancement.

• Supportive work environment and team culture.

• Flexible work schedule options.