Clinical Research & Operations Manager

Responsibilities:
· Clinical Site Management
· Conduct feasibility assessment for potential sites
· Direct contact with clinical sites internationally
· Monitor site compliance
· Logistical management of trial subjects including patient compliance
· Site support and training
· Enhance recruitment and motivation of patients
· CRO management
· Support and management of clinical operational activities
· Defining processes
· Implement processes
· Support in design and management of clinical documents
· Routine clinical and project management activities; before, during and after the study
· Ethical regulatory submissions in Europe and USA
· Working with external suppliers
· Support of regulatory, QA and R&D departments within the organization
 
Requirements
· Degree in life science/medicine or similar.
· At least 5 years’ experience in clinical operations, in a medical device international environment.
· Knowledge of regulatory submission and reporting requirements and guidelines.
· Experience in project management and demonstrate the ability to meet project requirements.
· Excellent interpersonal skills
· Must work both independently and in a team environment.
· Proven organizational abilities, and excellent written and oral communication and presentation skills.
· Fluent verbal and written Hebrew and English
· Full proficiency with Office software
· Basic technical skills
· Ability to travel abroad frequently- up to two travel to Europe/month