Medical Research & Operations Manager
Hybrid · Seoul, Seoul, South Korea
Job Summary
Lead and oversee all Non-Interventional Studies (NIS) operations, including regulatory PMSS, Access Program(PAA/PTA), Multi-country NIS (MCNIS), Affiliate-Sponsored Studies, and IIS, ensuring compliance with corporate, ethical, and legal requirements. Manage medical research operations, provide line management and mentorship to the medical research & operation team, coordinate workload and resources, drive study budgeting and planning (LRP and tracking), monitor quality and compliance, and guide strategic expansion of study types (e.g., Post Trial Access, IP supply IIS, Collaborative research) with cross-functional teams.
Required Qualifications
- Bachelor’s degree in pharmacy, nursing, or relevant scientific discipline
- Significant clinical research experience (more than 7 years-preferred)
- Excellent knowledge of clinical research practices, local regulations, and ICH guidelines
- Advanced skills in Project Management (schedule, budget, communication, resources, and quality)
- Experience in people management and leadership, including performance appraisal
- Fluency in English (written and spoken)
Desired Qualifications
- Bachelor’s degree in pharmacy, nursing, or relevant scientific discipline
- Significant clinical research experience
- Advanced project management skills (schedule, budget, communication, resources, quality)
- Experience in people management and leadership
- Excellent verbal and written communication skills in English
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