Biospecimen Project Manager - Scientific Operations (Finance)
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 travel 2 - 4 times per year in Cambridge, MA
