Job Description

Key Responsibilities:

• Lead and manage all 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 field (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
• Must reside in the Raleigh-Durham-Chapel Hill area , with availability to work on-site as needed for meetings and collaboration

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