Advanced Recruiting Partners
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