Manager, Clinical Operations, International (based in Europe) at Cabaletta Bio
Interview Preparation Plan
This role at Cabaletta Bio is responsible for overseeing and managing clinical operations across international sites in Europe. The Manager will ensure that clinical trials are conducted in compliance with all relevant regulations, protocols, and company standards. This involves strategic planning, site selection, budget management, and cross-functional team leadership to drive the successful execution of clinical development programs. The position requires a deep understanding of international clinical trial conduct, regulatory landscapes in Europe, and operational excellence. The Manager will play a critical role in the day-to-day management of clinical trials, including monitoring site performance, managing vendors, and ensuring data integrity. They will be a key liaison between internal teams (e.g., R&D, regulatory, project management) and external partners (e.g., clinical sites, CROs), fostering strong relationships and effective communication. This role demands strong problem-solving skills, adaptability to evolving project needs, and a commitment to patient safety and data quality.
Key Responsibilities
- Oversee the planning, execution, and completion of international clinical trials in Europe.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and local/international regulations.
- Manage clinical trial budgets, timelines, and resources effectively.
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