Neonatal Clinical Trial Manager – Global Trials

Aerogen Pharma Limited; Morrisville (NC); Hybride; USD 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Competitive bonus plan

Above market life insurance

Opportunities for development

Résumé du poste

Aerogen Pharma, a US-based clinical-stage company, seeks a Clinical Trial Manager to lead start-up, site management, and monitoring for complex global trials. You will coordinate vendors, ensure data integrity, and maintain regulatory compliance under GCP/ICH standards.

You will drive risk management, KPI reporting, and trial documentation while partnering with Regulatory Affairs and QA to ensure inspection readiness. A leadership mindset and strong communication are essential.

Qualifications

• 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 CFR, GCP/ICH guidelines and other regulatory requirements.
• Proficiency in Office software suites (Word, Outlook, PowerPoint, Excel) and collaboration tools.

Responsabilités

• Independently manage specified components of a clinical trial and oversee vendors.
• Ensure trial activities and deliverables meet CFR, GCP/ICH, and Aerogen SOP standards.
• Contribute to risk identification and mitigation with QA and senior leadership.
• Identify, evaluate and select clinical trial sites.
• Collaborate with study sites to ensure proper conduct of studies.
• Develop and implement operational solutions for monitoring activities.
• Review vendor invoices against SOW and budgets.
• Provide KPI reporting and quality issue identification for assigned vendors.
• Prepare Trial Master File documents for inspection readiness.
• Develop study documents and tools (ICFs, plans, budgets, templates).
• Assist in creating regulatory documents with Regulatory Affairs.

Connaissances

Regulatory compliance

GCP/ICH Knowledge

Leadership

Vendor management

Project management

Effective communication

Formation

RT or RN or Bachelor's degree in related field

Outils

Microsoft Word

Excel

PowerPoint

Outlook

Description du poste

Aerogen Pharma, a US-based clinical-stage company, seeks a Clinical Trial Manager to lead start-up, site management, and monitoring for complex global trials. You will coordinate vendors, ensure data integrity, and maintain regulatory compliance under GCP/ICH standards.

You will drive risk management, KPI reporting, and trial documentation while partnering with Regulatory Affairs and QA to ensure inspection readiness. A leadership mindset and strong communication are essential.