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Job Opportunity: Clinical Trials Manager

 
Date   Nov 22
 
Listing No.   IE270089
 
Sector   Medical & Healthcare
 
Region   Center
 
City/Yishuv   Tel Aviv
 
 
Clinical Trials Manager
 
Responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Own on-site & interdepartmental training as well as on-site clinical and technical support.

Main Job Responsibilities and Duties

1. Execute all operational aspects of the company’s clinical studies
2. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
3. Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with company timelines; identify areas of concern and escalate to Director of Clinical affairs.
4. Perform initial review of third-party study vendor invoices
5. Data management and study tools development.
6. Develop and maintain good working relationships with investigators and study staff.
7. Investigate queries, monitor discrepancies as applicable.
8. TMF maintenance and ensuring the trial is “audit ready” at all times
9. Work collaboratively with cross functional internal and external teams
10. Become a clinical expert of the Company’s technology and being able to perform comprehensive training sessions
11. Development of presentations and handouts
12. Perform site monitoring/co-monitoring, upon need
13. Willing to travel within Israel and to US & EU, upon need

REQUIREMENTS

Professional Skills and Qualifications

Education and Experience

1. Bachelor's degree or equivalent, in a biomedical, life science or related field of study. Advanced degree is preferred.
2. At least 2 years of trial management experience in Medical devices as well as a minimum of 2 years’ experience as a CRA.
3. Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
4. Previous experience in working with US sites, IRBs.

Personal Skills

1. Highly motivated, self-starter, able to work independently & proactively
2. Detail oriented
3. Ability to prioritize tasks and resources, meet deadlines, and flex to changing priorities
4. Excellent collaboration skills, strong team player
5. Excellent written and oral communication and presentation skills
6. Excellent computer skills
 
 
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