Lead and manage operational aspects of global clinical trials from study start-up through close-out
Oversee study timelines, deliverables, and budgets to ensure milestones are met
Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct
Oversee site activation, clinical monitoring, data integrity, and adherence to protocol
Conduct study-level risk assessments and ensure inspection readiness
Manage safety and pharmacovigilance activities in collaboration with internal and external teams
Lead internal and external study meetings; provide training to relevant stakeholders
Contribute to the development of study-related documents and clinical study reports
Perform other duties as needed to support successful trial execution
Qualifications :
Bachelor’s degree in life sciences or a related (advanced degree preferred)
Minimum of 8 years of clinical trial management experience, particularly in Phase 2 / 3 respiratory trials
Demonstrated success in leading global trials and working with cross-functional and vendor teams
Deep understanding of GCP, ICH guidelines, and global regulatory requirements
Specific therapeutic experience in respiratory diseases, especially COPD , strongly preferred
Strong project management, problem-solving, and communication skills
Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel
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Clinical Trial Manager • Raleigh, NC, US
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