Job Description

The Biospecimen Project Manager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies.
Responsibilities
Drive biospecimen lifecycle management from sample receipt to analysis and final disposition
Ensure accurate specimen metadata
Transfer analytical data to clinical repository
Increase the efficiency of specimen management through sharing of knowledge and best practices
Participate in or lead special projects as assigned
Adhere to client policies and Standard Operating Procedures
Review nonclinical and clinical study protocols and service providers' scope of work documents for sample handling and processing details
Set up study and electronic protocol in LIMS
Create and manage project plans
Manage data transfer plans with analytical laboratories
Manage specimen metadata discrepancies and ensure resolution
Submit specimens for analytical assays per study timelines
Provide specimen updates of received specimens and data to study teams
Review status of specimens received and completeness of data in data system; create reports for study teams when requested
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
Participate in and/or lead process improvement projects under direction of manager
Support manager in providing projections for annual and long-term planning
Education/Experience
Understanding of transaction-based inventory and data management systems as well as clinical trial processes
Understanding of ICH, GCP, GLP, and local regulations
Proficient in Excel, macro and template building knowledge
Strong planning, organizational, time management skills
Experience with StarLIMS or other LIMS for biospecimen management
B.A./B.S. in life sciences, medical technology, or related field and 3-5 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.

Skills Required