Senior Vendor Laboratory Manager Clinical Laboratory & Biospecimen Management
On-siteSan Rafael, California, United States
Job Summary
Lead program-level laboratory and biospecimen management oversight for complex clinical studies, ensuring activities align with protocol requirements, timelines, and decision-making needs. Provide senior-level oversight of study start-up, maintenance, close-out, and vendor transitions while identifying cross-study dependencies and driving resolution through structured action plans. Serve as a functional subject matter expert for assay intended use, biomarker implementation, and biospecimen governance, triaging responses to health authority questions and supporting audit readiness. Manage strategic vendor relationships, including sourcing, contract modeling, and performance oversight for central and specialty laboratories, while coaching junior staff on financial reviews and operational execution.
Required Qualifications
- PhD degree with life sciences/laboratory background, including biomarkers
- 5+ years of project management, clinical operations, laboratory operations, biomarker operations, specimen management, or vendor management experience
- Master's degree with life sciences/laboratory background, including biomarkers
- 8+ years of relevant experience
- Bachelor's degree with life sciences/laboratory background, including biomarkers
- 10+ years of relevant experience
- Relevant professional experience in the pharmaceutical/biotechnology industry
- clinical research setting
- clinical/diagnostic laboratory
- central laboratory
- specialty laboratory
- biorepository
- CRO
- clinical operations
- translational sciences operations
- biomarker operations
- vendor management environment
- Strong knowledge of clinical drug development
- strategic planning for clinical research
- ICF
- ICH GCP
- GLP
- IVDR 2017/746
- GDPR
- clinical laboratory specimen handling
- assay intended use
- Strong understanding of human biospecimen lifecycle management
- informed consent implications
- biorepository operations
- research-use requests
- specimen integrity
- disposition processes
- Demonstrated experience managing complex clinical trial protocols
- global vendor relationships
- laboratory deliverables
- biomarker workflows
- biospecimen-related data pathways
- Demonstrated experience leading cross-functional initiatives beyond assigned studies
- influencing decisions without direct authority
- Strong strategic thinking
- scenario planning
- negotiation
- operational judgment
- ability to build structure from ambiguity
- Strong understanding and experience with risk identification
- mitigation planning
- issue resolution
- quality management
- execution through close-out
- Comprehensive understanding of financial and contract documents
- invoice reconciliation
- accruals
- scope alignment
- cost modeling
- budget variance communication
- Proven ability to mentor staff
- develop operational capability
- lead matrix teams
- communicate effectively at study, program, and functional leadership levels
- Project management skills
- Support the organisation's commitment to environmental protection
- injury prevention
- continual improvement of EHS management systems
- Actively contribute to a safe and environmentally responsible workplace
- identifying hazards
- reporting incidents
- participating in EHS initiatives and training
Desired Qualifications
- Project Management Professional (PMP) certification preferred
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