Manager, Biomarker Operations
Job Summary
To oversee biospecimen collection and logistics for clinical development programs, the full-time remote Manager, Biomarker Operations will manage tracking systems, collaborate with cross-functional teams, and ensure compliance and quality throughout the clinical trial lifecycle.
Key Responsibilities
- Serve as the operational lead for biospecimen collection, processing, shipment, and inventory management across clinical studies
- Develop and maintain study-specific biospecimen management plans and documentation, ensuring compliance and inspection readiness
- Collaborate with internal teams and external vendors to drive biospecimen collection activities and manage operational oversight of biomarker laboratories
Required Qualifications
- Bachelor's degree in Biology, Life Sciences, Clinical Laboratory Science, Biomedical Sciences, or related field
- 5+ years of relevant experience for Manager level or 8+ years for Senior Manager level in biotechnology, pharmaceutical, CRO, or clinical research settings
- Direct experience managing clinical trial biospecimens and working with biomarker or translational medicine teams
- Experience setting up and operating central laboratories and managing external vendors
- Knowledge of clinical trial regulations, ICH-GCP, and biospecimen operational best practices
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