Biospecimen Project Manager
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Job Description
Biospecimen Project Manager overseeing clinical-study sample lifecycle, metadata, and laboratory data. Managing trackers, project plans, analytical transfers, and database-lock readiness for a sponsor.
Responsibilities:
- Serve as the centralized point of contact for biospecimen lifecycle management and resulting analytical data from clinical studies
- 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
- Improve specimen management efficiency by sharing knowledge and best practices
- Provide site support and drive query resolution
- Participate in or lead special projects
- 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 complex study sample trackers
- Create and manage project plans
- Manage data transfer plans with analytical laboratories
- Manage data received from external and internal laboratories, including exploratory studies
- Manage specimen metadata discrepancies and ensure resolution
- Submit specimens for analytical assays according to study timelines
- Review specimen receipt status and data completeness
- Support database locks by ensuring all specimens have final results and data transfer is complete
- Create reports for data management as needed
- Support annual and long-term planning projections
- Provide support and act as a technical resource within the department
Requirements:
- 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, and 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
Benefits:
- 100% remote work arrangement
- Ability to work standard east coast business hours
- Potential maximum travel 2–4 times per year in Cambridge, MA
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