Clinical Study Manager

Role: Clinical Study Manager (CSM) leading clinical operations for Liquidia’s pulmonary hypertension programs. Responsibilities: oversee study planning and execution, vendor management (CROs, labs), site initiation, protocol development, budget management, and regulatory compliance. Lead cross-functional collaboration with Medical, CMC, and QA teams; ensure documentation accuracy; monitor study progress and data quality; and support regulatory inspections. Requirements: Bachelor's degree with 5+ years in clinical research, including 2+ years in study management; experience managing external vendors and clinical teams; strong knowledge of GCP, FDA regulations, and clinical trial processes; excellent communication, organization, and problem-solving skills. Preferred: experience with pulmonary hypertension or biologics, strong vendor negotiation skills, and proficiency with project management tools. HighValue: clinical trial execution in a small biotech setting, managing Phase 1-3 pulmonary hypertension studies, vendor oversight, and regulatory compliance. WorkSetup: flexible, potentially remote with up to 30% travel.