Manage and coordinate global clinical trials from study design to closeout, ensuring compliance with ICH-GCP and sponsor SOPs. Collaborate with teams for study execution, risk management, and timely delivery of clinical trial deliverables. Proactively communicate study status, risks, and mitigation strategies to ensure on-time and on-budget execution.

The Start Up Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning. Will act as Subject Matter Expert for questions by other in-country members supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents.

The Regulatory Affairs Specialist will support frequent minor software releases and the EU MDR application. This role involves cross-functional collaboration for product changes, maintenance of documentation, and managing new product registrations. This individual will play a key role in HeartFlow regulatory activities for product changes.