Clinical Director – JD

Responsibilities:
 Design and develop all clinical study documents, Submits all relevant study documents to EC/IRB, CA and/or FDA, local authorities and institutions.    
Responsible for coordination/execution of all operational aspects of clinical studies, including study establishment, patient enrollment and follow up,  study closure activities.     
Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.   
Leading the management of protocols; prepares protocol, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial.    
Establish ongoing liaison with key opinion leaders, government officials, and healthcare organizations and ensure that significant developments in the field are identified and monitored.    
Run the clinical studies in multi-center and being the primary point of contact to site on all project matters, collect and present the data collected.          
     Requirements:
 The clinical Director background should be either from the medical field with an engineering or biomed path.   
At least 7 years’ of experience in leading and managing clinical trials in a medical device environment in European and or Us markets (highly preferable both markets).    
Have a comprehensive knowledge base of the local requirements of Ethics Committees and Competent Authorities submission procedures according to international and national laws and guidelines.   
A regulatory experience is a benefit.   The position requires constant travel overseas