Senior Biospecimen Project Manager

LabConnect is a company focused on scientific and consulting services, and they are seeking a Senior Biospecimen Project Manager to oversee the biospecimen lifecycle management and analytical data from clinical studies. This role involves driving specimen management efficiency and providing oversight to junior personnel while ensuring compliance with client policies and protocols.

Responsibilities:

• Drive biospecimen lifecycle management from sample receipt to analysis and final disposition
• Ensure accurate specimen metadata
• Communicate study specimen updates to client groups and stakeholders
• Increase the efficiency of specimen management through sharing of knowledge and best practices
• Provide site support and drive query resolution
• Participate or lead special projects as assigned
• Adhere to client policies and Standard Operating Procedures
• Review clinical study protocols and service providers’ scope of work documents for sample handling and processing details
• Set up and maintain a complex study sample tracker – experience in manual sample tracking for complex clinical studies
• Create and manage project plans
• Manage data transfer plans with analytical laboratories
• Manage data received from external and internal laboratories, including data generated in exploratory studies
• Manage specimen metadata discrepancies and ensure resolution
• Submit specimens for analytical assays per study timelines
• Review status of specimens collected and completeness of data
• Contribute to meeting database locks by ensuring all specimens have a final result and data transfer is complete; create reports for data management as needed
• Provide guidance to others and act as technical resource within the department
• Lead projections for annual and long-term planning to clinical team
• Provide oversight and management to junior personnel

Requirements:

• Understanding of transaction-based inventory and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations
• Strong excel experience required, extensive macro and template building knowledge desired
• Strong computer literacy, including Word, SharePoint, Smartsheet and PowerPoint
• Advanced planning, organizational, time management skills
• B.A./B.S. in life sciences, medical technology, or related field and 5-7 years of directly related experience
• Experience in life sciences or medically related fields, including clinical development, biospecimen lifecycle management, or clinical laboratory analysis
• Very high attention to detail and excellent multi-tasking skills is required for success in this position
• LabMatrix experience preferred
• Project Management experience is also preferred