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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?
In conjunction with the Lead Clinical Trials Manager and under the overall direction of the Head of Clinical Operations (HCC), the Clinical Trial Manager will be responsible recruitment, initiation, conduct (day to day operations) and close-out of clinical trials for the AeroFact program.
Duties and Responsibilities
• Coordinating & tracking monitoring visits for the field clinical monitoring team
• Tracking and coordinating team project-specific and SOP training for the field CRA staff.
• Reviewing, tracking, and finalizing monitoring visit trip reports and follow-up letters
• Coordinating the trial start-up efforts and management of the regulatory documents to ensure sitAssoe readiness for SIVs
• Managing the eTMF
• Managing clinical supplies in conjunction with the unblinded CRA.
• Creating and implementing study-specific plans (clinical monitoring plan), clinical monitoring tools and documents.
• Assuring compliance with Aerogen Pharma’s SOPs, local regulations, and CFR, ICH/GCP guidelines.
• Participation in initial creation of screening, data collection forms, and database/data entry screens.
• Support site specific development of IRB submission packages or Aerogen Pharma central IRB submissions.
• Field/Remote Monitoring/Co-monitoring as needed.
• Participation in site qualification, site initiation visits, interim monitoring visits an close-out visits as necessary.
• Perform field evaluation of monitors at pre-determined intervals or as needed.
• Oversight of study progress and day to day operations with sites (PIs, Coordinators, & other research staff)
Education and Experience
• RN, RT or bachelor’s degree in a science-related field or equivalent job experience.
• >5 years’ experience in the clinical trials field or a related field
• Strong communication skills, both verbal and written
• Proficient in Microsoft Office Word/Excel/PowerPoint
• Understanding and use of multiple EDC platforms
• Ability to work independently and prioritize multiple deliverables simultaneously
• Ability to work well in a team environment
• Available to travel up to 50%
• Valid driver’s license and passport
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 centralise 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.
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?
In conjunction with the Lead Clinical Trials Manager and under the overall direction of the Head of Clinical Operations (HCC), the Clinical Trial Manager will be responsible recruitment, initiation, conduct (day to day operations) and close-out of clinical trials for the AeroFact program.
Duties and Responsibilities
• Coordinating & tracking monitoring visits for the field clinical monitoring team
• Tracking and coordinating team project-specific and SOP training for the field CRA staff.
• Reviewing, tracking, and finalizing monitoring visit trip reports and follow-up letters
• Coordinating the trial start-up efforts and management of the regulatory documents to ensure sitAssoe readiness for SIVs
• Managing the eTMF
• Managing clinical supplies in conjunction with the unblinded CRA.
• Creating and implementing study-specific plans (clinical monitoring plan), clinical monitoring tools and documents.
• Assuring compliance with Aerogen Pharma’s SOPs, local regulations, and CFR, ICH/GCP guidelines.
• Participation in initial creation of screening, data collection forms, and database/data entry screens.
• Support site specific development of IRB submission packages or Aerogen Pharma central IRB submissions.
• Field/Remote Monitoring/Co-monitoring as needed.
• Participation in site qualification, site initiation visits, interim monitoring visits an close-out visits as necessary.
• Perform field evaluation of monitors at pre-determined intervals or as needed.
• Oversight of study progress and day to day operations with sites (PIs, Coordinators, & other research staff)
Education and Experience
• RN, RT or bachelor’s degree in a science-related field or equivalent job experience.
• >5 years’ experience in the clinical trials field or a related field
• Strong communication skills, both verbal and written
• Proficient in Microsoft Office Word/Excel/PowerPoint
• Understanding and use of multiple EDC platforms
• Ability to work independently and prioritize multiple deliverables simultaneously
• Ability to work well in a team environment
• Available to travel up to 50%
• Valid driver’s license and passport
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 centralise 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.
Location
USA
USA
Department
Pharmaceutical
Pharmaceutical
Job Title
Clinical Trial Manager
Clinical Trial Manager
Salary
Experience
City
San Mateo, CA
San Mateo, CA
Country
United States
United States
