Biospecimen Project Manager
Summary
Serves as the central point of contact managing the full biospecimen lifecycle for a sponsor's clinical studies — from sample receipt and metadata accuracy to data transfers with labs and final disposition. Works 100% remotely on East Coast hours, using LIMS, inventory/data management systems, and Excel with macros.
Job Summary:The Biospecimen Project Manager, part of our Functional Service Provider (FSP) Solutions division, will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies for one of our sponsors.
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
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 received 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
Support manager in providing projections for annual and long-term planning
Provide support to others and act as technical resource within the department
Experience/Education/Skills Required:
B.A./B.S. in life sciences, medical technology, or related field, required
3 - 5 years experience managing biospecimen samples from receipt to analysis and final disposition, required
Understanding of transaction-based inventory and data management systems as well as clinical trial processes
Understanding of ICH, GCP, GLP, and local regulations
Project Management experience strongly desired
Excellent communication skills
Strong planning, organizational, time management skills
Very high attention to detail and excellent multi-tasking skills
Proficient in all Microsoft products, including Excel, with macro and template building knowledge
Experience with LIMS systems
Hours/Location:
100% remote, ability to work standard east coast business hours
Potential maximum travel 2 - 4 times per year in Cambridge, MA