Study Director

Minimum qualifications:

A master's degree

Hiring:

3

Experience requirements:

1 - 3 years

Working area:

Shanghai Fengxian


Job Responsibilities:

 

1. Write, sign, and revise the test plan;

 

2. Ensure effective communication with quality assurance personnel before and during the start of the test, and promptly address issues and suggestions raised by the quality assurance department;

3. Ensure that staff involved in research topics have easy access to test protocols, protocol revisions, and corresponding SOPs;

4. Organize scheme discussion and learning, timely convene relevant personnel to discuss the stage progress of the responsible project, and notify the department head;

5. Ensure that the test plan is strictly implemented during the test implementation process, record any abnormalities that deviate from the test plan or SOP during the test process, evaluate their impact on the test quality and integrity, and take appropriate corrective measures if necessary;

6. Master the progress of work, check various experimental records, and ensure timely, accurate, and clear recording;

7. Ensure that the computer system/experimental instruments tested during the test are verified;

8. Timely communicate and negotiate with the principal investigator (PI) and other relevant personnel to promote the smooth progress of the trial;

9. Write and sign a summary report to evaluate the compliance with GLP during the implementation of the test;

10. After the experiment is completed, ensure that the experimental plan, original data, specimens to be preserved, various relevant record files, and summary reports are archived and preserved;

11. Implement the provisions of SOPs, and timely propose suggestions for revising or supplementing corresponding SOPs;

 

Job Requirements: 

1. Master's degree or above, with a background in pharmacology, toxicology, pathology, veterinary medicine, clinical medicine, or related majors;

2. More than 2 years of safety evaluation experience in toxicology, pharmacology, pathology, and more than 2 years of GLP related work experience; The device industry is preferred; Familiar with NMPA/FDA/OECD requirements for testing; Be able to independently design, guide, operate tests, and write reports;

3. Work rigorously, conscientiously and responsibly, with strong principles, good communication skills, professional ethics, and team spirit;

4. Fluent English communication skills (written and spoken English);