Senior Biospecimen Project Manager
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
Skills/Abilities:
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 PowerPointAdvanced planning, organizational, time management skills
Experience / Education:
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.