Location: Gyeonggi-do
Contract Type: Permanent
Salary: ₩50,000,000 – ₩70,000,000 per annum
A leading ultrasound medical device company is recruiting a Clinical Project Manager to plan and operate clinical trials. We welcome applications from professionals with 3+ years of CRA and CRO management experience.
Responsibilities:
- Plan and manage clinical trials
- Manage and monitor clinical trial sites
- Collect and report adverse events (AE) using CTCAE, MedDRA coding
- Support preparation of interim reports and Final Clinical Study Reports (FCSR)
- Respond to audits and submit documents to regulatory authorities (MFDS, FDA, EMA)
- Share data and schedules with global headquarters and overseas clinical teams
- Conduct literature reviews and analysis
- Manage and update documents for global clinical trial sites
Requirements:
- Bachelor’s degree or higher in medicine, life sciences, nursing, pharmacy, or related field
- 3+ years of CRA and CRO management experience
- Hands-on experience with MFDS GCP/ICH-GCP guidelines required
- Proficiency in MS Office
- Ability to draft English documents and communicate effectively via business email
- Willingness and ability to travel and work abroad
- Strong documentation and reporting skills
- Strong compliance mindset with respect to principles and procedures
- Understanding of MFDS regulatory responses and global approval processes
Preferred Qualifications:
- Clinical experience with medical devices and pharmaceuticals
- Project Manager experience and/or PMP certification
- Practical CRA/CRC or hospital clinical experience (nurse/clinical pathologist background)
- Understanding of medical writing or prior experience as a Medical Writer
- Statistical analysis skills and CRO management experience
About the Company:
An ultrasound medical device company preparing for global expansion following successful clinical trial outcomes.