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1. Set up clinical evaluation strategy for new products.
2. Clinical trial project management (timeline, budget, compliance, etc.).
3. Coordinate clinical trial protocol drafting.
4. Coordinate CER drafting.
5. Support RA on clinical subjects from NMPA and other stakeholders.
6. Support key prospective initiatives like Hainan RWS and investigational study to pipelines.
7. Any other daily tasks from line manager.
Qualifications Knowledge, Skills and Abilities:
? Proficient knowledge of clinical study and clinical evaluation including the related regulations.
? Strong project management skills.
? Conducts self in a professional manner with suppliers, coworkers and management.
? Ability to communicate effectively in both written and oral form with all levels of management.
? Detailed oriented and organized.
? Intermediate skill in the use of Excel, Word and PowerPoint.
Work Environment: General office environment.
Experience: Minimum 2-3 years of related experience in clinical trial and clinical evaluation for medical device.
Education:
? Bachelor degree in related majors.
? Experience in optical industry is a plus.