Job Summary:
The Biospecimen Project Manager, part of FSP Solutions, will oversee the full end-to-end lifecycle of biospecimens, ensuring efficient tracking, management, and data integrity from collection through final disposition for the client. This role involves establishing streamlined processes, implementing monitoring systems, and ensuring stakeholders have seamless access to data. A key focus will be driving process improvements and exploring opportunities for automation to enhance operational efficiency.
Responsibilities:
- Drive biospecimen lifecycle management from sample receipt through analysis and final disposition, ensuring compliance with study timelines and client requirements.
- Establish uniform specimen tracking practices across the portfolio, ensuring standardization and harmonization of processes from end to end
- Setup and maintain complex study sample trackers, ensuring accurate, complete, and real-time data availability of specimen status for all stakeholders involved
- Leverage real-time monitoring systems to promptly identify and resolve anomalies, ensuring accurate specimen information and metadata throughout the biospecimen lifecycle
- Provide site support and drive query resolution
- Pull, compile, and manage data from various sources including EDC, testing labs, central labs, and multiple databases, ensuring comprehensive data tracking.
- Ensure cross-functional utility and accessibility of biospecimen tracking systems for all key stakeholders, improving transparency and collaboration.
- 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
- 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
Education/Experience/Skills Required:
- B.A./B.S. in life sciences, or related field and 3-5 years of directly related experience managing the full specimen life cycle, from collection to disposition.
- Experience in clinical development, biospecimen lifecycle management, clinical laboratory analysis, or a related field is essential.
- Highly proficient in Excel, with macro and template building knowledge
- Experience with QuartzBio, required
- Project management expertise is highly desirable.
- Strong planning, organizational, prioritization time management skills
- Understanding of inventory management and data management systems as well as clinical trial processes
- Understanding of ICH, GCP, GLP, and local regulations
Work Location/Hours/Travel:
- 100% remote with possibility of travel approximately twice a year to the client site
- Ability to work daily core business hours of 10am - 4pm Pacific Time, with the other hours flexible based on location