Vectorious’ has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease, keeping them stable, out of hospitals, and living longer, fuller lives.
About this role:
The Clinical Specialist will have primary responsibility for various clinical trial management duties within our clinical team and will be reporting to VP Clinical Affairs. The ideal candidate should have a previous experience in supporting and managing live procedures in cath-lab environment and in conducting clinical trials under GCP.
-Responsibility for the preparation of study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, amendments and regulatory authorities annual updates, as required
-Design, format and review of CRFs, study guides, study reference binders, and forms including participating in the EDC specification process
-Maintaining GCP Compliance in the company’s clinical activities via periodical co-monitoring, audits issues and inspections activities
-Assessing quality of work of sub-contractors including monitoring visits, co-monitoring or oversight visits with CROs, protocol deviation management, and on-regular-basis communications with the study centers personnel
-Monitoring and tracking clinical trial progress and providing status update reports
-Verify payments to the clinical department suppliers and align with Finance
-Development of project documentation