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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 min 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.