Clinical Research Associate/Manager (Global)

Now is our time to inspire the future of healthcare together.

Mediwhale Inc. is a venture-backed oculomics AI company from South Korea. We are looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity.

Our flagship platform solution utilizes ophthalmic-based artificial intelligence to enable personalized cardiovascular disease (CVD) risk prediction. Built on a series of patented machine learning algorithms, our regulator-cleared software as a medical device platform provides convenient CVD risk assessment in point-of-care settings.

Core Duties and Responsibilities

As a CRA, you will be responsible for independently managing all aspects of global clinical research. This includes overseeing on-site clinical studies, ensuring adherence to timelines, and maintaining high-quality documentation. You will collaborate with local investigators, provide feedback to cross-functional teams, and contribute to product development and regulatory processes. This role requires frequent travel to study sites and reports directly to the Head of Clinical Operations in Singapore.

. 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 study start-up to close-out, 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.

Required Education, Experience,Knowledge, and Skills

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

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

. Thorough understanding of medical device clinical trial design, ISO 14155 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.

. 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 globally as required.

Contact Details

If you are interested in finding out more information about this opening, please contact Mediwhale SG office in-charge ([Confidential Information]).