Sr .Clinical Operations Manager, ICON Clinical Research, Tel Aviv, Israel

Managing the ICON Israeli clinical activity for the last 4 years.
Prior to ICON, 12 years of clinical research experience in global pharma companies.
Last role before ICON: PM in Teva R&D department

Education

The Hebrew University
B.sc.
Food chemistry biochemistry

The University of Derby.
Master (MBA)
Business Administration

Summary
•    Over 18 years of experience working in clinical research with over 15 years of experience as CRA or Project Manager

•    Over 4 years of experience working for ICON Clinical Research as a Clinical Operations and country  Manager
•    Clinical Research Therapeutic Areas include:

     Cardiovascular
     Oncology
     Hematology
     Gastroenterology
                   Neurology
                   Endocrinology
                   Gynecology
                   Infectious diseases
                   Respiratory
                   CNS

Professional Experience
ICON Clinical Research    Job Description

Sr. Clinical Operations and country manager
Apr 2012 to present     Managing  the activities related to both SSU and CRA departments In the SSU department : Responsible for the preparation, review and approval of country related and site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards;  ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment. Ensure SSU team compliance with ICON systems and procedures.
Ensure appropriate allocation of resource and optimal utilization of SSUAs.
Support the team in study start up related issues.
Continually assess opportunities for process improvements and develop and monitor process change implementation.
Develop supporting staff skills, encourage growth and provide regular performance feedback.
In the CRA department: continue with the same CRA management responsibilities I had since I joined ICON on Feb 2012.  

Job Description
Managing  all the clinical activities related to both SSU and CRA departments in ICON Israel
In the SSU department : Responsible for the preparation, review and approval of country related and site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards;  ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment. Ensure SSU team compliance with ICON systems and procedures.
Ensure appropriate allocation of resource and optimal utilization of SSUAs.
Support the team in study start up related issues.
Continually assess opportunities for process improvements and develop and monitor process change implementation.
Develop supporting staff skills, encourage growth and provide regular performance feedback.
In the CRA department:.
•    Coordinating the optimization of the performance of the CRAs.
•    Monitor and evaluate CRA’s workload and liaise, ensure appropriate allocation of resource and optimal utilization of CRAs.
•    CRA performance reviews and appraisals, Put in place development plans where required.
•    Identify and ensure all necessary training is provided to CRAs on an ongoing basis.
Accompany and ensure that CRAs are accompanied on their visits

Business development : responsible to connect between local Israeli pharma companies to ICON global business development department in order to perform those companies global clinical trials                                                                                                                                         
Teva Pharmaceuticals LTD
Clinical Trials Project Manager Feb 2007 to Dec 2011     Project manager of the Teva Innovative R&D  drugs Clinical Research Department in Teva Israel and Turkey, assuming the following responsibilities:
•    Managing 7 CRA's and 4 CTA'S  both  Israeli and Turkish , conducting phase II and III studies
•    Responsible for the communication with the sponsor and the investigators selection with the head of the clinical trial of investigators and eligibility of study sites.     
•    Assist the Principal Investigators with the submission of the protocol and amendments to the Helsinki Committee or to the regulatory authorities.
•    On- going during the study evaluation local resources for conduct of study
•    Oversee the performance of the CRA's and CTA’s.
•    Regular and continuous review of the study's progress and reporting of the study status to the sponsor Implementing SOP's and in the decision making process
Schering Plough Israel
Senior CRA +Project Manager
Jul 2002 to Feb 2007    

•    As a SCRA: perform SSU and Monitoring tasks in Israel, of phase II and III Schering plough international studies.
•    As Project Manager: Managing  CRO monitors (outsource) in monitoring clinical research projects, locally and internationally, at phases  III and IV, at all stages, which include:
•    Managing Project from the very first stage of planning and budgeting, threw the  selection of the  investigators among the sites medical staffs, control of writing the protocol and the  CRF (for local studies), drawing of contracts, submitting of Helsinki and MOH  Requests, control the monitoring of the  studies at all stages up to publishing of results paper.
Aventis Pharma    
CRA
Jan 1998 to Jul 2002    Managing and monitoring FDA controlled clinical research projects, locally and internationally, at phases II III and IV, at all its stages.