Full Time

Clinical Project Lead

Posted 1 month ago
Application ends: November 12, 2021
Apply Now

Job Description

Job Summary

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.

Essential Functions

  • 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.

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’s degree in related majors.
  • Experience in optical industry is a plus.

Job

Administration

Primary Location

China

Organization

CVI Quality Assurance Manufacturing

Schedule

Full-time

Unposting Date

Ongoing