Spain
Managing Partner of TRIQ Group (Consultancy) (Since August 2014 - 2024) Owner and Clinical Research Consultant of BVBA MED-I-MART (Since January 2009 - ongoing) Continue to excel in the current and any future contract roles I have an all-round experience in medical devices, pharmacy and biotech, although I have never been involved in the engineering part of the business. Great language skills, excellent interpersonal skills, great adaptive skills. Home-based in Belgium but travel extensively. Latest update: your one-stop-shop for excellence in search and selection of clinical research positions Specialties: International monitoring Medical Devices - Pharma Trials, FDA , GCP and ISO 14155 guidelines. Quality Assurance, auditing (internally, site audits, affiliate audits), writing/reviewing SOPs Line management/coaching group of junior and senior CRAs with different levels of experience. Sponsor and CRO oversight management. Language skills Dutch (mother tongue), excellent English, French and German. Good notions Spanish. Great interpersonal skills, leadership, diplomacy. Excellent knowledge of medical device environment Audit experience in Europe, Asia, North-Africa, Middle East and North-America and Canada. INDICATIONS * Cardiology, Cardiovascular, Cardiac Surgery, Atrial Fibrillation/Arrhythmias, (Congestive) Heart Failure, Hypertension, Vascular Intervention * Obesitas * Pain Relief, Chronic Pain Management * Migrane * Neuromodulation, DBS, Chronic Back Pain * Oncology: Ovarian cancer, Fallopian cancer, Primary Peritoneal cancer, Melanoma, Colorectal cancer, Prostate cancer, Lung cancer * Infectious diseases: Aspergillosis, Candidemia and other fungal infections, Sexually Transmitted Diseases * Complex abdominal hernia * Sleep apnea DEVICE KNOWLEDGE: Pacemakers, Defibrillators, CRT-P, CRT-D, artificial and biological Heart Valves, Stents, Internal Vessel Occluders, Ablation Therapy, Septal Closure of PFO, Gastric Bands, Neurostimulators, etc. PHARMA KNOWLEDGE: wide range of drugs in above indications
Unmasked Monitoring Oversight and Co-monitoring
Monitoring, project management, auditing, training, interim management Fluent in Dutch-Flemish, French, English, German and Spanish Worldwide international experience
CRO oversight