Under general direction from Sr. RAQA Manager, the Clinical Project Lead will be responsible for new products’ clinical study and clinical evaluation for China, along with providing support to key prospective initiatives including Hainan real world study and investigational study to pipelines.
- Set up clinical evaluation strategy for new products.
- Clinical trial project management (timeline, budget, compliance, etc.).
- Coordinate clinical trial protocol drafting.
- Coordinate CER drafting.
- Support RA on clinical subjects from NMPA and other stakeholders.
- Support key prospective initiatives like Hainan RWS and investigational study to pipelines.
- Any other daily tasks from line manager.
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.
General office environment.
Minimum 2-3 years of related experience in clinical trial and clinical evaluation for medical device.
- Bachelor’s degree in related majors.
- Experience in optical industry is a plus.
CVI Quality Assurance Manufacturing