Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit and follow us on LinkedIn and X (Twitter).


Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease.  We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company.    To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team.  In this way, we are not only working to improve the lives of patients, but of everyone involved. 


About the Position

Reporting to the Senior Director GCP Compliance, the TMF Inspection Readiness Associate is an integral member of Quality and Compliance team.  The position is responsible for the complete and accurate Trial Master Files through documentation of quality, consistency, and timely filing across all assigned clinical trials, consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency and any other local authority requirements.  Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness, and timeliness in the eTMF for all studies, working with the study teams and vendors. Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional, clinical research studies throughout the lifecycle of the trials.




  • Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and CABA policies as it relates to the completeness and accuracy of the TMF at the study level by ensuring the required documents reside in the TMF as per the Study-Specific Master Plan and Master List and are always inspection ready.
  • Work with TMF Study Lead and study team to define the TMF Plan and to build the Study Master list from the Toolkit – TMF Master List.
  • Define expected documents for the study and maintain appropriate placeholder or Expected Document Lists in the eTMF system in collaboration with Study team .
  • Work proactively and prospectively with TMF Contributors to ensure timely uploading of all Essential Documents in the TMF.
  • Periodically perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule.
  • Resolve noncompliance with overdue quality review findings and overdue “In-Progress” eTMF documents, which will improve the accuracy of the TMF.
  • Monitor and identify TMF trends and escalate concerns to management.
  • At study completion, ensure the TMF is ready to be archived.
  • Coordinate the long-term storage archival of original documents and maintain document integrity per retention policies.
  • Manage complex export requests for Health Authorities and divestitures and independently solve technical issues.
  • Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
  • Assist in overall change management and build collaborative relationships with cross-functional teams and third-party vendors.
  • Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection.
  • Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines.
  • Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
  • Provide support to TMF implementation, internal audits, and regulatory inspections.
  • Demonstrate ability to make decisions, deliver on commitments, share knowledge, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.




Degree Requirements

  • Minimum of Bachelor’s degree in a scientific or related discipline.
  • Experience Requirements At least 3 years of TMF experience required, including experience in study start-up, maintenance, and closeout, and performing quality and completeness reviews.
  • Relevant experience in clinical trials related roles (i.e. clinical operations and project management). Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.

Key Competency Requirements

  • Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (E6(R2)).
  • Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology.
  • Must have knowledge of Core, Country, and Site level essential documents.
  • Must have ability to navigate eTMF system and show advance proficiency with Window Office tools.
  • Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review.
  • Very strong communication and interpersonal skills, verbal and written, is required.


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


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.