Sr. CRM - CPS & DC

Job description

  Job facts

Job Summary:
1. Set up Action Plan and conducts clinical studies for product registration purpose in a timely manner and with the most cost efficient manner.
2. Establish and maintain the good and closed relationship with lab chiefs. Builds up and represents Roche Diagnostics' good image.
Main Tasks & Responsibilities:
1. Lead a team, work across-functional to complete clinical studies for product registration purpose. Achieve RD expectation on product registration.
2. Set up clinical trail SOP and update SOP in time, improve working efficiency.
3. Evaluate and determine clinical protocol and clinical report.
4. Establish and maintain the good relationship with key opinion leaders. Recommends valuable suggestion to company
5. As a member of RD, provide active and strong technical supports to internal dept. as needed.
6. Ensure the compliance of Good Clinical Practice and other regulations

Basic Requirements of the Job:
Education& Qualifications:
1. At least Bachelor degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering
2. Proficiency in both spoken and written English
3. Good command of MS office software application
4. Understand medical device regulation

Experience:
At least 5 years of working experience in either a Medical Device or Diagnostics industry, and 2 years of working experience in clinical study of IVD/Medical Device/Drug

Health Conditions:
According to the 'Quality Management Regulations for Medical Device Management' and the 'Regulations on Quality
Management of Pharmaceutical Products', health checks should be conducted at least once a year; if you have infectious
diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.

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