Clinical Trial Manager

About Aerogen Pharma: Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination 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 combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.

We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.

Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

Join us as we embark on this breakthrough and become inspired to deliver.

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. This includes vendor management, monitoring subject safety and data collection, and ensuring investigational site compliance with the protocol and applicable regulatory regulations. The CTM also acts as a liaison between Aerogen Pharma and the investigational site and helps to troubleshoot any issues that arise during the trial.

It is a highly collaborative role, requiring an aptitude towards leadership, effective communication and project management skills, as well as a deep understanding of the regulations and ethical considerations surrounding clinical research.

What are the key responsibilities?

• Independently manage specific components of a clinical trial as assigned, provide oversight of vendors and work cross-functionally within Aerogen Pharma to achieve study success. The assigned clinical trial may be of high complexity or high risk.
• Ensure clinical trial activities and deliverables are completed on time in a highly dynamic and complex environment in accordance with the applicable Code of Federal Regulations, appropriate quality standards including GCP/ICH requirements and Aerogen Pharma SOPs.
• Contribute to risk identification and mitigation plans for Clinical Operations and escalate potential quality risks in a timely manner working closely 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 to ensure effective study monitoring activities at participating clinical sites to ensure compliance with the study protocol and timeline projections, adherence to applicable regulatory obligations and collection of high-quality data.
• Review and recommend approval of vendor invoices against the scope of work (SOW) and study budget forecast for assigned vendors, working closely with Clinical Operations senior leadership and Aerogen Pharma Finance to proactively identify and correct variances.
• Provide oversight for assigned vendors, report key performance indicators (KPI), and proactively identify quality issues.
• Responsible for contributing high-quality required documents for inclusion in the Trial Master File to ensure inspection readiness.
• Assist in the development of study documents and tools including informed consent forms, project plans, budgets, logs, templates, newsletters, and others, as needed.
• Contribute to the creation of technical documents such as clinical trial applications, protocols, protocol amendments, clinical study reports and investigational drug brochures working closely with Aerogen Regulatory Affairs.
• Provide vendor status updates and reports to senior management on request.
• Participate in ongoing study data reviews…