Senior Manager, Biospecimen Lead
Core
Oversees biospecimen management (collection, shipment, storage, analysis, disposition) for 5-15 clinical trials to ensure timely data delivery and regulatory compliance.
Role type
Senior Manager, Biospecimen Lead
Builds
Clinical trial data infrastructure and biospecimen strategies
Domain
Biopharmaceuticals / Clinical Research
Required skills
Biospecimen lifecycle management, Vendor oversight, Risk mitigation, Protocol authoring, Data reconciliation, SOP development, Cross-functional leadership, Training and mentorship
Preferred skills
Advanced knowledge of GCP/GLP/CLIA, Experience with Central Labs/CROs, Change Agility, Innovation in workflow optimization
Technologies
Internal/External tracking systems, Contracting systems, Custom tracking solutions
Responsibilities
Develop Specimen Management Plans, Track and reconcile biospecimen status, Provide biospecimen expertise in protocol authoring, Act as liaison between clinical teams and vendors, Participate in vendor audits and resolve CAPA issues, Lead cross-functional projects to optimize workflows, Provide training and mentorship for junior staff
Seniority
Senior Manager, hands-on IC with strategic oversight