CBI - Biospecimen Lead (BSL)
Core
Manage biospecimen operations for 5-12 clinical trials, developing management plans and ensuring data delivery timelines.
Role type
Senior IC clinical operations manager (biospecimens)
Builds
Specimen management plans and operational workflows for Phase 1-4 clinical trials
Domain
Biopharmaceuticals / Clinical Research
Required skills
Biospecimen lifecycle management, vendor management, protocol authoring input, data reconciliation, risk mitigation, cross-functional collaboration, training/mentorship
Preferred skills
Therapeutic area knowledge, GCP/GLP/CLIA understanding, change agility, innovation in workflows
Technologies
Internal/external tracking systems, contracting systems, CAPA resolution tools
Responsibilities
Develop specimen management plans with risk mitigation, track and reconcile sample status, liaise with clinical teams and vendors, maintain inspection-ready study documents, participate in vendor audits, provide training to new colleagues
Seniority
Senior, hands-on IC