Contract Type: Permanent
Salary: ₩50,000,000 – ₩70,000,000 per annum
Location: Gyeonggi-do
Clinical Project Manager
A medical device company specializing in ultrasound devices is seeking a Clinical Project Manager to oversee clinical trial planning and operations. We welcome applications from professionals with 3+ years of CRA experience and CRO management background.
Responsibilities:
- Plan and manage clinical trials
- Manage and monitor clinical sites
- Collect and report adverse events (AEs) (CTCAE, MedDRA coding)
- Support preparation of interim and final clinical study reports (FCSR)
- Prepare and submit documentation to regulatory authorities (MFDS, FDA, EMA) and respond to audits
- Share data and timelines with global headquarters and overseas clinical teams
- Conduct literature reviews and analyses
- Manage and update global clinical trial site documentation
Requirements:
- Bachelor’s degree or higher in a relevant field (Medicine, Life Sciences, Nursing, Pharmacy, etc.)
- At least 3 years of CRA and CRO management experience
- Hands-on experience with MFDS GCP/ICH-GCP
- Strong proficiency in MS Office
- Ability to write English documents and professional business emails
- Willingness to travel and work abroad
- Strong documentation and report development skills
- Integrity and adherence to principles and procedures
- Understanding of MFDS procedures and global regulatory approval processes
Preferred Qualifications:
- Clinical experience with medical devices or pharmaceuticals
- Project Manager experience and/or PMP certification
- CRA/CRC experience, or hospital clinical background (nurse/clinical pathologist)
- Experience as a Medical Writer
- Statistical analysis skills and CRO management knowledge/experience