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Cabaletta Bio Inc Logo Cabaletta Bio Inc · IT - Administration

Clinical Sample Manager

United States · Job Posted May 16, 2026
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Job Description

The Clinical Sample Manager will support the management and coordination of day to day clinical sample activities for cell therapy trials. This role ensures the accurate tracking, handling, and documentation of clinical samples throughout the lifecycle of the study. The position requires close collaboration with clinical teams, external vendors, and laboratories to ensure samples are processed and analyzed according to study protocols and regulatory requirements.

Job Responsibility

  • Support the Senior Clinical Sample Manager overseeing end-to-end clinical sample tracking and chain of custody, maintaining real-time logs from site collection through central and specialty laboratories
  • Ensure sample integrity and compliance with stability windows, including scheduling shipments and reviewing/approving manifests for transfers between central and third-party labs
  • Support sample reconciliation across systems, identifying and resolving discrepancies to ensure data accuracy, escalating risks as needed
  • Support site start-up and ongoing operations as needed, including initiating kit shipments and maintaining accurate lab contact distribution lists, central lab SIV and ad-hock trainings
  • Support ongoing review of site supplies and ensure sites have kits for upcoming collections on site
  • Log trends and risks in sample handling (e.g., shipment deviations, site errors) and communicate proactively with both internal and external stakeholders
  • Support the Senior Clinical Sample Manager in reviewing and maintaining central lab documentation, including lab manuals and related study documents
  • Update internal SM documents as needed post protocol amendments
  • Serve as a secondary reviewer for sample management and central lab documentation to ensure quality and compliance
  • Review protocol amendments for lab budget impacts, supporting updates, routing for approval, and execution of change orders as needed on an individual level
  • Participate in site initiation and cross-functional meetings, representing sample management, along with other Clinical and Operations staff
  • Maintain organized documentation and audit-ready records, including meeting minutes, agendas, SRFs, and DCFs
  • Ensure proper filing and traceability of sample-related documentation within study systems and internal SharePoint

Requirements

  • Bachelor's degree in Life Sciences or a related scientific discipline required
  • Minimum 5 years of experience in clinical sample management within a biotechnology, pharmaceutical, CRO, central laboratory, or cell/gene therapy environment
  • Minimum 2 years of hands-on experience supporting laboratory sample processing, specimen handling, chain of custody, and/or biospecimen operations
  • Strong understanding of GCP, GLP, IATA, and applicable regulatory requirements governing clinical sample collection, shipment, reconciliation, storage, and disposition
  • Experience managing complex sample logistics and oversight activities across central laboratories, specialty laboratories, depots, and clinical sites
  • Proficiency with LIMS, CTMS, EDC systems, and sample tracking platforms
  • Experience supporting sample reconciliation activities between EDC, central laboratory databases, and/or vendor systems
  • Ability to review and interpret study-specific laboratory manuals, sample flow plans, and protocol-related sample handling requirements
  • Strong organizational skills with demonstrated ability to manage multiple studies, priorities, and timelines simultaneously in a fast-paced clinical environment
  • Excellent attention to detail with strong analytical and problem-solving capabilities
  • Strong written and verbal communication skills with experience collaborating cross-functionally with Clinical Operations, Data Management, central labs, vendors, and investigative sites
  • Ability to work remotely and independently while maintaining a strong collaborative and team-oriented mindset
  • Demonstrated ability to identify operational risks, trends, and process improvement opportunities related to sample management activities
  • Strong sense of accountability, adaptability, and commitment to continuous learning and professional development

Nice to have

  • Experience supporting cell therapy, gene therapy, immunology, oncology, or other complex biomarker-driven clinical trials
  • Prior experience supporting ex-U.S. and global clinical studies
  • Experience managing a portfolio of multiple concurrent Phase II and/or Phase III clinical studies globally
  • Familiarity with specialty sample types, stability windows, and time-sensitive sample shipment coordination
  • Experience overseeing third-party laboratory vendors and external sample management partners
  • Prior involvement in central laboratory start-up activities, including kit forecasting/distribution, lab manual review, and sample management planning

What we offer

  • health and retirement
  • PTO
  • stock option plans
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