The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the HeartFlow Clinical Research staff and collaborate effectively with HeartFlow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Assisting Managers with clinical pends and over-read feedback, assigning manual assignments, and aiding individual data entry production, while reviewing daily QA reports, this role ensures collaboration among cross-functional teams for product releases. Additional duties are necessary to meet client obligations.

The Safety and Quality Specialist will provide field-based support to practice teams across Northern Ireland, Ireland & one area of Scotland (Glasgow or Edinburgh) in all aspects of dental regulation, including the requirements of our key regulators and the delivery of high -quality care to our patients. The Safety and Quality Specialist will support a culture of quality improvement and ensure a consistent approach to quality standards across all practices, whilst maintaining local accountability.

Identify regulatory requirements related to the product and implement best practices for monitoring, interpreting, and communicating changes to internal teams. Proactively monitor, investigate, interpret, and communicate changes to regulatory requirements that may impact the current product. Work directly with product management to translate regulatory requirements into Veeva’s framework for use within our suite of applications.

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. Supports products within the Oncology TA.