Senior Biospecimen Project Manager

Role Description

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

Please note: This is a remote role is open to candidates based in the United States. Candidates located in California are eligible only if they reside outside of the San Francisco Bay Area (defined as locations more than 100 miles from the Bay Area).

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

Qualifications

• Understanding of transaction-based inventory and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations
• LabMatrix experience preferred
• 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

Requirements

• 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
• Project Management experience is also preferred
• Very high attention to detail and excellent multi-tasking skills is required for success in this position