Biospecimen Project Manager
Remote · United States or Johnson City, Tennessee, United States
Job Summary
Biospecimen Project Manager responsible for developing and leading processes to drive biospecimen lifecycle management from sample receipt through analysis and final disposition or long-term storage. Establishes and maintains a complex study sample tracker, dashboards, and data-tracking tools; ensures accurate specimen metadata; communicates study updates to client groups and stakeholders; coordinates transfer processes between vendors and sites; supports study setup with intake forms and data management; reviews protocols and scope of work for sample handling; leads or participates in special projects; ensures adherence to SOPs and regulatory frameworks (ICH, GCP, GLP); collaborates with Translational Sciences and Clinical Trial Management teams, vendors, and partners; provides site support, query resolution, and reporting; requires strong PM skills, vendor management experience, familiarity with LIMS, data management systems, and regulatory requirements; this is a 6-month temporary role with potential extension.
Required Qualifications
- B.A./B.S. in life sciences, medical technology, or related field and a minimum of 2-3 years of directly related experience
- Experience in biospecimen lifecycle management required, with experience in life sciences or medically related fields such as clinical development or clinical laboratory analysis
- Strong Project Management experience, with demonstrated organizational skills required
- Vendor Management (bioanalytical and specialty laboratories) with outsourcing experience preferred
- Budgeting and forecasting experience preferred
- Excel experience, macro and template building knowledge
- Experience within sample tracking platforms, LIMS systems, SharePoint required
- Experience with Clinical Maestro preferred
- Very high attention to detail and excellent multi-tasking skills
- Ability to lead projects within a cross-functional matrix
- Understanding of ICH, GCP, GLP, and local regulations required
- Ability to draft SOPs, work instructions, templates required
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