Clinical Trial Risk Based Monitoring Jobs in Raleigh, NC

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 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 needed.
• Develop and deliver study training to investigators, site staff, vendors and internal staff on the protocol and select study processes.
• Manage study supply inventory and distribution activities at the study and site levels.
• Participate in the preparation of Clinical Operations responses to internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections working closely with Aerogen Regulatory Affairs and Quality Assurance.
• Participate in internal and external (e.g., Investigator Meetings) Clinical Operations meetings for assigned clinical trial(s).
• Participate in the RFP and vendor selection process.
• Train new clinical trial staff on study specific processes.
• Other responsibilities as assigned.
What education and experience are required?
• 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 in biotech,
pharmaceutical, academic and/or CRO environment.
• 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 applicable regulatory requirements.
• Demonstrated proficiency in Office software suites such as Microsoft Word, Outlook, PowerPoint, Excel and various collaboration and productivity tools
What key skills will make you great at the role?
• Strong communication and conflict resolution skills.
• An aptitude towards or demonstrated capability for leadership.
• Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical trial.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
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 driven industry leaders in drug development and commercialization, 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.
What is it like to work at Aerogen?
Our purpose is to transform patient lives, and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There's something for everyone! Here is an idea of what we offer:
• Competitive bonus plan.
• Above market life insurance.
• Opportunities for development and professional growth.
• "Aerogen Connect" - our employee-led program that helps our global teams unite and have fun.
• We donate 1% of profits and time to charities and organizations.
Visit our careers website for more information about life at Aerogen.
Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at [email protected]. Please provide your name and preferred contact method.