Global Clinical Trial Manager


About the company:

Pi-Cardia is a medical device start-up company developing a novel low profile catheter for the treatment of Aortic Stenosis. The company's proprietary technology is based on delivering mechanical impact for creating scoring lines in valve calcification, without injuring the surrounding soft tissue. This treatment, which only takes several seconds, is intended to increase the valve effective orifice area without the need to replace the valve.

Job description:

•Preparation of new studies with Pi-Cardia's products: sites selection,
materials, submissions, contracts, EDC, CRO’s selection etc.
•Study management: sites, core labs and service provider's, monitors,
data management, safety, insurance, budget etc.
•Execution of US pivotal clinical trials, in specific, for market approval
purposes, in line with FDA regulations
•Establish strong relationships with site investigators and other KOLs
•Conduct periodic site visits (engagement and management)
•Administrative clinical department support

Required qualifications:

• 4 + years Clinical Affairs
•B.Sc. in life science/medical science
•Strong knowledge of GCP, 21 CFR, ISO 14155, MDR
•Experience with a large-scale US or EU Pivotal Trial
•Excellent written and oral English communication skills, including
proficiency in scientific/medical terminology
•Excellent communication, presentation, interpersonal and problem-
solving skills
•Ability to work independently as well as collaboratively in a start-up
•Good organizational skills
•Overseas travel 20%

Job location

Rehovot Science Park, Israel