담당업무

·      Independently generate, write, and edit study protocols, informed consents, case report forms, study reports, monitoring plans, and other clinical and regulatory documents.

·      Manage pre- and post-market clinical studies from initiation to closure, ensuring compliance with industry standards, best practices, and study protocols.

·      Maintain the trial master file and oversee study-related documentation, including medical images.

·      Prepare for and conduct investigators' meetings, fostering effective communication and collaboration.

·      Resolve discrepancies and address issues promptly, working closely with site personnel.

·      Directly contribute to study recruitment and informed consent procedures.

자격요건

·      PhD, PharmD, RN or equivalent; BA/BS degree with relevant healthcare background may be considered.

·      Minimum 2 years of independent clinical trial management in Korea, preferably in medical devices.

·      Thorough understanding of medical device clinical trial design, MFDS regulations and other applicable industry standards.

·      Proficiency in medical terminology related to cardiology, nephrology, and ophthalmology desired.

·      Strong written and oral communication skills in both English and Korean.

·      Ability to build and maintain effective relationships with trial center colleagues and staff.

·      Excellent time management and prioritization abilities, with a keen attention to detail.

·      Willingness to travel domestically as required.