Experience

RedDress Ltd.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Clinical Team Leader (CTL)

  • Aug 2017 - Present

  • Design, approve and execute of pilot, pivotal and post marketing medical device clinical trials. • Develop Pilot, Pivotal and Post Marketing Clinical Trials protocols. • Prepare clinical trial documents, including: ICF, CRF and study logs. • Select investigators and research centers in Europe and USA and participate in monitoring visits. • Prepare Ethics Committee/ Institutional Review Board submissions and reports in USA, Israel and Europe. • Prepare and execute of training programs for the clinical staffs. • Negotiate clinical trial agreements, manage investigator payments according to study milestones. • Manage supplies and logistics for the trial. • Evaluate, select, and oversee all trial vendors (CRO, EDC, IDC, central IRB) and their deliverables. • Trial data management. • Pre-Clinical and Bench tests protocol co-development and execution Show less



MitralCord Ltd.

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Clinical Affairs

  • 2013 - 2018

  • Clinical and Pre-Clinical Protocol development. • Pre Clinical Ethics Committee submissions • Pre-Clinical trials execution and management and reports writing • Work in collaboration with R&D department • Prepare applications and reports to Israel Innovation Authority grant • Clinical and Pre-Clinical Protocol development. • Pre Clinical Ethics Committee submissions • Pre-Clinical trials execution and management and reports writing • Work in collaboration with R&D department • Prepare applications and reports to Israel Innovation Authority grant