15 years’ experience in clinical operations and 5 years in quality assurance, having worked for and with small and large CROs, several small start-up companies in medical devices, biotech as well as big pharma / medical devices companies. Project Management experience with European coverage. GCP auditing - Vendor auditing - Internal audits - Inspection readiness preparation,QMS set up with particular focus on startup phase clients. International clinical research experience in Italy, Belgium, the Netherlands, UK, France, Spain, Austria, Luxemburg, Sweden, Portugal, Switzerland, Serbia, Israel and Germany. Site feasibility, qualification, initiation and monitoring until close-out. Experience in training and coaching (study specific protocol training, ICH GCP training, inspection readiness, informed consent, training in house and on request for clients).SIV training and additional site training per request. Accompanied site visits. On the job training of junior CRAs. Training for non-clinical staff about clinical research. Medical writing (Informed consent, study documents) and translations. CRF design. Current Location: Belgium. Language Expertise: professional proficiency in Dutch – Italian – French - English – German – Spanish – Swedish.