Responsible for the clinical aspects of medical device projects at all stages (including support to R&D, regulatory process and training), Focusing on operating company's clinical studies.
1. Full support to R&D with regards to medical devices processes, including: a. Planning and execution of ex-vivo, in-vivo and clinical trials b. Clinical application requirements (feedback to R&D on hardware, software, ergonomics etc.) c. Procedure's protocol establishment d. Risk management process
2. Full support of Regulatory / Clinical Strategy, including a. Preparation and establishment of clinical knowledge, scientific documentation such as clinical evaluation reports b. Development and execution of Post-marketing clinical plans
3. Planning and execution of clinical trials according to GCP and following company SOPs including: a. Contract negotiation with sites b. Maintaining and improving relationships with physicians/investigators c. Preparation of trial related documentation d. Organizing Ethics committee
submissions e. Performing study initiation’s visits, site monitoring and training and study termination visit f. Data collection, analysis and reporting g. Collaborating with physicians towards publication of study results
4. Scientific and strategic evaluation of ISTs, request from grants, etc.
5. Supporting physicians with publications, and presentations
6. Active participation in scientific meetings / lectures / congresses
7. Support marketing activities from the scientific/clinical point of view in strategic thinking, planning and execution
8. In house and abroad training as requested by VP
9. Writing clinical SOP’s
10. Special Projects Management
Education and experience
1. At least M.sc in a relevant field (Biology, medical science, bio-engineering etc.); PhD is an advantage!
2. At least 3 years’ experience of clinical affairs management, in a medical device related company
· Should be familiar with the main clinical guidelines such as the GCP and the clinical ISO standards
· Should be able to initiate and perform a clinical study according to the required regulations
· Should be able to write clinical documents, SOPs, forms
· Should be able to review clinical and scientific articles Skills
· Fluent English. Native English speaker is an advantage!
· Excellent communication skills.
· Attention to detail is extremely important.
· Flexible and has the ability to adapt quickly to changing regulations
· Excellent organizational, analytical, project management skills
· A team player
· Ability to work under pressure and to meet strict deadlines · Knowledge of reference manager software (Mendeley/ EndNote) and Microsoft
Word formatting with styles are advantages
· Integrity, transparency and a professional approach to work, tact and diplomacy