Clinical Trial Manager

About Aerogen Pharma: Aerogen Pharma is a US-based clinical-stage specialty pharmaceutical company whose mission is to develop inhaled drug/biologic and device combinations that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary, and commercially differentiated combination products by pairing proven therapeutic molecules with a unique, high-performance aerosol delivery system. What is the role? The Clinical Trial Manager (CTM) is responsible for managing various aspects of clinical trials, including study start‑up, site management, and monitoring activities. The CTM oversees vendor management, monitors subject safety and data collection, and ensures investigational site compliance with the protocol and applicable regulatory regulations. Acting as a liaison between Aerogen Pharma and the investigational site, the CTM troubleshoots issues that arise during the trial. The role requires leadership, effective communication, project management skills, and a deep understanding of the regulations and ethical considerations surrounding clinical research. Key Responsibilities Independently manage specific components of assigned clinical trials, provide oversight of vendors, and work cross‑functionally within Aerogen Pharma to achieve study success. Trials may be of high complexity or high risk. Ensure trial activities and deliverables are completed on time in a dynamic and complex environment in accordance with the Code of Federal Regulations, quality standards including GCP/ICH requirements, and Aerogen Pharma SOPs. Contribute to risk identification and mitigation plans for Clinical Operations and, when necessary, elevate potential quality risks in a timely manner with Clinical Operations senior leadership and Aerogen’s Quality Assurance. Participate in the identification, evaluation, and selection of clinical trial sites. Partner efficiently, effectively, and professionally with participating study sites to ensure proper study conduct. Create and implement tactical operational solutions that support effective site monitoring activities, ensuring protocol compliance, timeline adherence, regulatory obligations, and high‑quality data collection. Review and recommend approval of vendor invoices against scope of work (SOW) and study budget forecasts, working closely with Clinical Operations senior leadership and Aerogen Pharma Finance to proactively manage variances. Provide oversight for assigned vendors, report KPI, and proactively identify quality issues. Contribute high‑quality required documents for inclusion in the Trial Master File to ensure inspection readiness. Assist in developing study documents and tools, including informed consent forms, project plans, budgets, logs, templates, newsletters, and others. Contribute to technical documents such as clinical trial applications, protocols, protocol amendments, clinical study reports, and investigational drug brochures in collaboration with Aerogen Regulatory Affairs. Provide vendor status updates and reports to senior management upon request. Participate in ongoing study data reviews and manage data cleaning activities. Manage CRAs assigned to clinical trials and activities related to site qualification, initiation, interim monitoring, and close‑out visits as required. Develop and deliver study training to investigators, site staff, vendors, and internal staff on protocol and selected study processes. Manage study supply inventory and distribution activities at the study and site levels. Participate in preparing Clinical Operations responses to internal process audits, vendor and site quality audits, and regulatory authority inspections in collaboration with Aerogen Regulatory Affairs and Quality Assurance. Participate in internal and external Clinical Operations meetings for assigned trials, including investigator meetings. Participate in the RFP and vendor selection process. Train new clinical trial staff on study‑specific processes. Other responsibilities as assigned. Education and Experience RT, RN, or Bachelor’s degree in a related field or equivalent combination of education, training, and experience. Minimum 6 years of experience in a clinical operations role within biotech, pharmaceutical, academic, and/or CRO environments. Experience with clinical study conduct from start‑up through close‑out in global clinical trials and CRO management experience highly preferred. Demonstrated ability to deliver project milestones on time. Knowledge of applicable Code of Federal Regulations, Good Clinical Practice/ICH Guidelines, and other regulatory requirements. Proficiency in Office software suites such as Microsoft Word, Outlook, PowerPoint, Excel, and other collaboration and productivity tools. Key Skills Strong communication and conflict‑resolution skills. Aptitude for or demonstrated capability in leadership. Application of problem‑solving techniques to resolve complex issues and risk‑management approach to identify and mitigate potential threats to trial conduct. Critical thinking to determine causes and appropriate solutions when issues arise. Moderate travel may be required, approximately 20%. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high‑performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from industry leaders in drug development, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of neonatal care, where potential is recognized and professional development is encouraged. Benefits Competitive bonus plan. Above‑market life insurance. Opportunities for development and professional growth. Aerogen Connect – an employee‑led program that helps global teams unite and have fun. We donate 1% of profits and time to charities and organizations. Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. #J-18808-Ljbffr Aerogen