About this role
Clinical Research Manager at BiVACOR. Location: Huntington Beach, California, United States. Role: Lead clinical operations, Mentor team, Ensure regulatory compliance Requirements: Senior clinical research leadership with 5+ years in medical device/pharma, US IDE experience, regulatory knowledge (FDA, ICH/GCP), and team management. Category: Research and Development (R&D) Seniority: Senior Level Tools: FDA Regulations, ICH E6(R2) GCP, ISO 14155:2020, Clinical Study Protocols, CSR, CEPs/CERs, Trial Master File, Clinical Data Interpretation Commitment: Full Time Workplace: Onsite Languages: English