Experience

CATO SMS

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager

  • Oct 2019 - Present

  • Responsible for managing the direction, planning, and execution of clinical trials and data collection activities and for assisting with the interpretation of clinical data. • Responsible for developing and maintaining collaborative relationship with the sponsor, investigative sites, and third-party contractors. • Provides input into design and implementation of clinical protocols, data collection systems, and final reports. Responsible for study setup and execution activities, including site selection, and preparation of regulatory submissions, study-specific forms, and tools, recruitment and enrollment strategies, oversight of monitoring activities, study conduct, compliance with regulatory standards, and completion of data transfer. • Prepares for and participates in audits. • Prepares study-related documents and reports of trial progress. • Interacts with various internal and external groups to facilitate conduct of clinical trials. • Prepares and performs study-specific training for the project team in face-to-face clinical research associate training and routine training during the study conduct. Show less



Cato Research Israel

• Senior CRA

  • Oct 2009 - Oct 2019

  • Experienced Senior CRA and Lead CRA with a demonstrated history of working in the pharmaceutical industry • Responsible for managing the direction, planning, and execution of clinical trials and data collection and cleaning activities • Conduct investigational site selection, initiation, periodic, accountability, and termination visits • Prepare study-related documents, tools and report on trial progress • Overseeing study conduct and third-party monitoring activities • Work closely with CRAs and CTMs. Provide clinical support and maintain communication with the clinical research site staff • Manage the clinical trial database • Responsible for preparing study submissions to the local ethics committees and the Israeli Ministry of Health • Support all study-related issues and documents • Assist in organizing and participate in investigators’ meetings • Responsible for monitoring multiple sites in a variety of indications including oncology studies • Maintain up-to-date investigator study files and Trial Master Files • Training and mentoring junior CRAs, provide oversight and guidance to contractor and vendor CRAs • Review monitoring reports of investigational site and ensure site compliance is maintained • Perform co-monitoring visits • Responsible for recruitment and enrollment strategies • In-depth knowledge of ICH-GC P guidelines and the various regulatory agency requirements Show less



Averion International

• United Kingdom
• Veterinary

• Clinical Trials Administration Manager and Quality Representative

  • 2005 - 2009

  - Prepared and tracked regulatory submissions and approvals - Trained junior clinical trial associates - Set up and maintained regulatory and investigator study files. - Organized and attended investigators’ and study team meetings. - Processed suspected unexpected serious adverse reaction (SUSAR) notifications in a timely manner. - Prepared and tracked regulatory submissions and approvals - Trained junior clinical trial associates - Set up and maintained regulatory and investigator study files. - Organized and attended investigators’ and study team meetings. - Processed suspected unexpected serious adverse reaction (SUSAR) notifications in a timely manner.



Sigma-Aldrich

• Biotechnology Research
• 700 & Above Employee

• Quality Assurance Technician

  • 2003 - 2005

  As a quality assurance technician, was responsible for immunological assays. As a quality assurance technician, was responsible for immunological assays.



XTL Biopharmaceuticals Ltd.

• Israel
• Pharmaceutical Manufacturing

• Research Assistant

  • 2001 - 2003

  As a research assistant, was responsible for cell biology and microbiology assays. As a research assistant, was responsible for cell biology and microbiology assays.