Lead, Clinical Operations

Skills

• Effective project management skills
• Exceptional knowledge of GCP, ICH, and FDA regulations
• Therapeutic experience in rare diseases or CNS conditions preferred

Responsibilities

• Directly manage the conduct of clinical trials from start-up through close-out
• Ensure compliance with SOPs, ICH-GCP guidelines, and patient safety standards
• Develop and report on metrics for clinical programs
• Contribute to the development of study documentation
• Manage relationships with CROs, vendors, investigators, and external partners

Education

• BS/BA Degree in science or a health-related field

Benefits