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Clinical Trial Manager
About Aerogen:
Headquartered in the vibrant city of Galway, Ireland with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter
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.
What are the key 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)
What education and experience are required?
• 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
What key skills will make you great at the role?
• 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
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:
•Excellent medical care.
•Bonus & Pension.
•‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
•We pledge 1% of profits and time to charities and organisations
Check out our careers website to discover more about Life at Aerogen
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
Headquartered in the vibrant city of Galway, Ireland with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter
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.
What are the key 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)
What education and experience are required?
• 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
What key skills will make you great at the role?
• 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
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:
•Excellent medical care.
•Bonus & Pension.
•‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
•We pledge 1% of profits and time to charities and organisations
Check out our careers website to discover more about Life at Aerogen
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
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
