Senior Manager, Clinical Laboratory Operations
$134,500–$168,228 year
HybridWaltham, Massachusetts, United States
Job Summary
Lead operational execution of laboratory sample collection, tracking, testing, reconciliation, data transfer, and final disposition across Zenas' clinical development programs. Plan and manage biomarker, bioanalytical, and central lab sample logistics, including kits, supplies, processing, shipment, storage, inventory tracking, chain of custody, and use tracking. Serve as the laboratory operations lead on assigned study teams, providing input into protocols, informed consent forms, laboratory manuals, sample management plans, and data delivery timelines. Oversee external laboratories, CROs, central labs, and specialty vendors, managing qualification, onboarding, performance, budget adherence, and contractual scope. Coordinate data transfer specifications, reconciliation outputs, and testing status updates with Translational Sciences, Data Management, and Clinical Operations. Support inspection readiness, quality activities, and process improvements by ensuring documentation completeness and resolving operational risks related to sample handling and reporting.
Required Qualifications
- Bachelor's degree in life sciences, clinical research, laboratory sciences, or a related discipline
- 6+ years of relevant experience in clinical sample management
- Strong working knowledge of clinical sample collection, processing, shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long-term sample storage requirements
- Demonstrated experience managing external vendors, including CROs, central laboratories, specialty biomarker laboratories, sample storage vendors, and other clinical trial service providers
- Experience supporting global clinical trials and working cross-functionally
- Familiarity with GCP, ICH guidelines, informed consent requirements, sample chain of custody, data privacy considerations, and clinical trial inspection readiness expectations
- Proven ability to manage multiple studies, vendors, priorities, budgets, and timelines in a fast-paced, matrixed environment with strong attention to detail and quality
- Excellent communication, collaboration, problem-solving, and organizational skills, with the ability to influence internal and external stakeholders and drive issues to resolution
- Comfort operating in a growing, entrepreneurial organization and contributing to process development, continuous improvement, and scalable biomarker operations infrastructure
Desired Qualifications
- Advanced degree
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