Experience

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  BrainQ Technologies

  • Jerusalem, Israel

  • Director of clinical trials

    • Aug 2021 - Present
    • Jerusalem, Israel

    A medical device company in the field of neurorecovery

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  Medinol

  • Kiryat Atidim, Tel Aviv

  • Global Clinical Trials Project Manager

    • Feb 2017 - Jul 2021
    • Kiryat Atidim, Tel Aviv

    A medical device company in the field of cardiovascular intervention.Responsible for trials management conducted in the US, EU and Israel. Oversee all aspects of trials conduct from study design, cost estimates, budgets negotiations, contract agreements management and study analysis on number of projects.Hold an overall responsibility for evaluating, selecting, managing and leading of global based sites, clinical teams, 3rd-party vendors, CRAs and CROs.Some of my accomplishments and duties: • Reduced clinical study costs by 50% by implementing a new department strategy of direct monitoring activities management instead of outsourcing to CROs in two projects.• Effective management of projects’ budgets and timelines within quality standards and established plans.• Multi projects, multi teams and global-based sites management: leading a staff of 5 CRAs, direct management of 17 sites (IL and UK) and 85 sites indirectly through CROs (US, EU, IL).• Achieved recruitment goals ahead of time. CSR submission to the FDA and getting FDA approval for the product early than expected.• Built a complete infrastructure, i.e. SOPs updates, development of study related documents and plans all within short period. • Supporting medical and regulatory teams in addressing MOH, FDA and European Competent authorities’ clinical questions and oversee the submission process to ECs and regulatory agencies.• Leading and development of study protocols (clinical aspects), related study CRF design and UAT, and clinical study report.• Managing risk mitigation strategies • Work in close cooperation with R&D and Marketing teams

• 

  ICON plc

  • Ireland
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Regional Clinical Trial Manager (CTM)

    • Oct 2013 - Feb 2017

    Lead clinical operations with oversight of and overall accountability for: site selection; site start-up (including submissions and investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. Responsible for risk mitigation strategies, associated action plan and issues resolution, and contributions to the cross-functional project management plans. Overall responsibility for managing the clinical operations project team and ensuring compliance with CRO/Sponsor SOPs, study contracts, budgets and quality standards. Providing training/mentoring to CRAs and ensuring a timely dissemination of information on study progress, issues, and/or processes to all team members related to the clinical deliverables. Managed trials conducted in EU, US, S. Korea, S. Africa.

  • Lead CRA

    • Jul 2012 - Oct 2013

    Primary point-of-contact for assigned CRAs to ensure the delivery of site management activities from site selection to close out, ensuring adherence with ICH/GCP, SOPs according to regulations, monitoring plan and studies budget.

  • Senior Clinical Research Associate (Snr. CRA)

    • Sep 2010 - Jul 2012

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  GCP Clinical Studies

  • Rosh Ha'Ayin, Israel

  • Senior Clinical Research Associate (Snr. CRA)

    • Oct 2006 - Sep 2010
    • Rosh Ha'Ayin, Israel

    Working experience with Genzyme and BMS.

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  Assaf Harofeh Medical Center Official Page

  • Wellness and Fitness Services
  • 200 - 300 Employee

  • ICCU Registered Nurse, Intensive Cardiac Care Unit

    • May 2000 - Jul 2007

  • RN, Team Leader and Head of Intermediate Cardiac Care Unit, Internal Medicine Department E.

    • Oct 1993 - May 2000

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  Omnicare, a CVS Health company

  • Rosh Ha'Ayin, Israel

  • Clinical Research Associate (CRA)

    • Jan 2003 - Sep 2006
    • Rosh Ha'Ayin, Israel

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  Mindsense Biosystems Ltd.

  • Rehovot Area, Israel

  • Research Assistant, CRA

    • Aug 2000 - Dec 2002
    • Rehovot Area, Israel

    A start-up company that developed a diagnostic blood-markers for Depression.