Senior Biospecimen Project Manager

Labconnect International Ltd • Cleveland, OH

7d

About The Position

The Senior Biospecimen Project Manager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies.

Requirements

• Bachelor s degree 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.
• Project Management experience is also preferred.
• Very high attention to detail and excellent multi-tasking skills are required for success in this position.
• Understanding of transaction-based inventory and data management systems as well as critical 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, and time management skills

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level