Clinical Project Manager

Job Summary

The Clinical Project Manager will manage U.S.-based clinical trial operations for company's medical AI products, focusing on site management, study conduct, and operational coordination with CROs, investigators, and headquarters. The ideal candidate has strong experience executing clinical studies (preferably SaMD or medical device), excellent organizational skills, and the ability to operate effectively in a cross-border environment.
Job Description

• - Oversee day-to-day clinical study conduct at U.S. sites, ensuring protocol adherence and regulatory compliance.
• - Manage site selection, initiation, monitoring, and close-out activities.
• - Coordinate with CROs, investigators, and clinical research staff to drive study progress.
• - Maintain study documentation, including TMF, monitoring reports, logs, and site records.
• - Track enrollment, study milestones, data collection status, and site performance metrics.
• - Support IRB submissions, amendments, and ongoing regulatory documentation.
• - Work closely with the Korean HQ clinical and product teams to ensure alignment across global
• studies.
• - Assist in vendor oversight, study budgeting, and operational issue resolution.

Qualifications

• - Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
• - Minimum 5 years of clinical research or clinical project management experience.
• - Experience with medical device or SaMD clinical trials strongly preferred.
• - Familiarity with GCP, FDA regulations, and IRB processes.
• - Strong communication and stakeholder management skills.
• - Ability to work independently across multiple time zones.
• - Bilingual fluency (English/Korean) highly preferred.
• - Experience working with academic medical centers or large hospital networks is a plus.

What's On Offer

Apply online or feel free to contact us directly for more information about the opportunity. Due to the high volume of applicant, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.