Clinical Sample Manager (Remote)

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

 

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

Clinical Sample Manager

Remote

About the Position:

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.

Responsibilities:

  • 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

 

Qualifications

  • 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.

Preferred Qualifications

  • 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.

 

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

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