Clinical Study Manager (CSM)

 Manages the overall planning, conduct and progress of clinical studies, and clinical operation. The CSM carry the responsibility for making sure the trial is planned and conducted under strict guidelines according to study protocol and regulation and according to company needs and timelines 
REPORTS TO: Director of clinical and regulatory affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Plan and execute clinical trials.
• Manage single and multi-center clinical studies worldwide including study timelines, budget, communication and stakeholders management
• Write clinical study documentation: protocols, Informed Consent, Investigator brochures, financial agreement, CRF and EDC, Submission package for IRB/EC approval, etc.
• Manage clinical studies preparation and approval internal process– coordinated with stakeholders involved in the study (R&D, product management, biostatistics, data management, investigators, customer support) in order to execute a clinical study from planning to publication stages
• Oversee the preparation, conduct and follow up of sites qualification, initiation, monitoring and close out visits in Israel and abroad and associated documentation 
• Perform clinical studies contract management 
• Manage studies insurance 
• Approve and oversee study payments and payments tracking
• Analyse clinical trials data and support preparation of scientific/medical reports and publications.  
REQUIREMENTS
• 5+ years experience as a study manager for medical device company or related field.
• Academic degree in life sciences.
• Extensive knowledge of ICH/GCP/ISO14155 regulations and guidelines
• CRA certificate
• Full working proficiency in English
• Experienced with Electronic Data Capture (EDC).
• Excellent communication skills, both verbal and written 
• Able to write reports and business correspondence.
• Proficient in Microsoft Office including Excel, PowerPoint and MS Project. 
• Possesses and applies problem-solving skills. 
• Able to work with details and complete assignments with minimal supervision.
• Highly motivated and goal oriented.
• Team player
• Very high communication, presentation and customer-service skills.
• Able to negotiate and build relationships at all levels.
• Willing to travel local and abroad 15% of the time