SOCRA Certified (CCRP) Clinical Research Specialist with over twenty years' experience in clinical operations in pharmaceutical and medical device industry along with regulatory and product development experience. Therapeutic areas of proficiency include Phase 2 and Phase 3 clinical trial oncology (Multiple Myeloma, Prostate, Breast) vascular disease, device oncology, orthopedics in regards to soft tissue dissections and coagulation, ENT. Sixteen years medical device manufacturing experience in multiple manufacturing roles including Supervisor.Skilled in Regulatory body Audit Preparedness, Site Nomination/Feasibility, Study Start-up, Site Management and Maintenance, CTMS, eTMF Expertise, IP Drug management, Vendor Management and Associate On-boarding/Training.Specialized in External Research Project management (IIRs) and EU-MDR industry preparedness which includes but not limited to CER creation, Post Market Clinical Follow Up, evaluation/analysis of product complaint data and medical literature.Proficient in knowledge of GCP | ICH | FDA | ISO regulations