Melissa Cohen

Biography

Director Company Name MDC Vision Dates Employed 2007 – Present Employment Duration 10 yrs Location Australia and UK Regulatory and clinical research consulting for the medical device industry for various companies in Australia, Europe, USA and Israel Clinical Affairs Director Company Name Stanmore Implants Dates Employed Nov 2014 – Dec 2015 Employment Duration 1 yr 2 mos Location Elstree, UK 1. Oversee and manage all operational aspects of the Clinical Affairs Department 2. Devise clinical strategy for the company 3. Provide direction and mentorship to staff including setting goals that are aligned with both Corporate and project goals. 4. Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct. 5. Vendor Selection and management 6. Approve clinical monitoring plans and prioritize study monitoring needs 7. Manage all time lines and budgets (internal/external) for clinical trials 8. Manage reports (direct/indirect), consultants and external partners 9. Write clinical SOPs for the company’s QMS. 10. Writing and reviewing clinical evaluations for all company devices. 11. Create and maintain Trial Master Files for clinical trials. 12. Maintain a high level of familiarity with clinical literature in orthopaedic implants and other applicable fields of study and the use of new tests and advances in clinical practice. 13. Providing clinical affairs induction to all new company employees 14. Leading clinical team through FDA remediation

Research Interest

 Pharmaceutical Science