Responsible for the clinical aspects of medical device projects at all stages (R&D including support of the regulatory process, training, marketing, and post-marketing) medical affairs activities, and special projects. 1. Full support of R&D process of medical devices, including:
* Planning and execution of ex-vivo, in-vivo and clinical trials.
* Clinical application requirements (feedback to R&D on hardware, software, ergonomics, etc.).
* Treatment's protocol establishment.
* Risk management process. 2. Full support of Regulatory / Clinical Strategy including:
* Preparation of clinical knowledge scientific documentation.
* Development and execution of Post-marketing clinical plan. 3. Planning and execution of clinical trials according to GCP and following company SOPs including:
* Contract negotiation with the site.
* Maintaining and improving relationships with physicians/investigators.
* Preparation of trial-related documentation.
* Organizing Ethics committee submissions.
* Performing study initiation visits, site monitoring, and training, and study termination visits.
* Data collection, analysis, and reporting.
* Collaborating with physicians towards the publication of study results. 4. Scientific and strategic evaluation of ISTs, request from grants, etc. 5. Lead the clinical knowledge in a specified field thus providing clinical evidence, training, and support to Alma members and sites. 6. Responsible for Clinical Information responses concerning the specific field for internal as well as external customers. 7. Supporting physicians with ALMA-related publications, white papers, posters, and presentations. 8. Active participation in scientific meetings / lectures / congresses. 9. Support marketing activities from the scientific/clinical point of view in strategic thinking, planning, and execution. 10. In-house and abroad training as requested by Global Clinical Education Manager or VP. 11. Special Projects Management.
Requirements: * PhD / MSC scientific degree.
* At least 3 years’ experience in the medical device industry.
* Proven experience in FDA multi-centered studies.
* CRA course graduate.
* Willingness to travel as needed (15-20%).
* Advantage - Experience in managing.
* Flounce English.
* Collaboration with regulation, marketing
המשרה מיועדת לנשים ולגברים כאחד.