Frederic Huebl

Background

About Frederic Huebl

Experience in clinical trial management of phase I – IV, pharma and medical device (MDR & IVDR) trials and unblinded/blinded and risk-based monitoring studies. and line management. Areas of Experience: • Financial and Resource Management • Line Management • Stakeholder Liaison • Process Improvement • Clinical Trials Coordination: Expertly oversee the conduct of clinical studies, ensuring compliance with GCP, AMG, MDR, IVDR, ISO 14155, ISO 15197, and ISO 17511. • Monitoring and Site Management: Perform co-monitoring visits with internal and external Clinical Research Associates (CRAs), as well as conduct clinical on-site monitoring activities, including patient recruitment, source data verification, and device/drug accountability. • Site Qualification and Initiation • Contract Negotiation and Document Management: Proficient in negotiating contracts with investigational sites and preparing/reviewing essential documents for submission to IRBs, Ethics Committees, and Regulatory Authorities. • eCRF Setup and Testing: Lead the setup of electronic Case Report Forms (eCRF), including User Acceptance Testing (UAT) to ensure functionality and compliance. • Archiving and Compliance • Training and Mentorship: Provide comprehensive training for internal and external study staff, fostering a culture of learning and excellence. Additionally, serve as a mentor for Clinical Research Associates. • Corrective and Preventive Action (CAPA) Management: Actively participate in CAPA management to address and resolve issues efficiently, contributing to continuous improvement initiatives. THERAPEUTIC AREA EXPERTISE: Cardiovascular: Peripheral vascular disease, chronic heart failure, atrial fibrillation, cerebral venous and dural sinus thrombosis, stroke Dermatology: Atopic dermatitis, psoriatic arthritis Endocrinology: Diabetes mellitus, painful diabetic peripheral Neuropathy, Diabetic Nephropathy Oncology: Chronic myeloid leukaemia, refractory multiple myeloma, Advanced or metastatic/refractory solid tumors, breast cancer Urology: Bladder pain syndrome, interstitial cystitis, Irritable bowel syndrome Metabolic disorder: Obesity and Overweight, Hyperlipidaemia Pulmonology : Idiophathic pulmonary fibrosis