Job Description

Main Responsibilities:

1. Write clinical trial protocol, clinical study report and related materials in clinical study (e.g. the clinical part of IND and NDA, or ethical materials);
2. Review clinical trial documents, such as Case Report Form (CRF), Statistical Analysis Plan (SAP), Data Management Plan (DMP) and Drug Safety Report Management Plan and so on. Make sure these documents are completed before the deadline;
3. Review medical information, find and solve related medical problems timely during clinical trials;
4. Make clinical development plan and complete clinical trial protocol design under the leadership of developing directors;
5. Solve medical problems and analyse data related to medicine in clinical study. Make sure the clinical study conform to clinical trial protocol, ICH, GCP and company SOP;
6. Communicate with clinical specialists and drug regulatory authorities on clinical study design and development strategies and so on;
7. To protect clinical projects carried out successfully, you should cooperate with operation teams, train them to learn about the medical part of clinical study and provide medical support for clinical study project start up.

Qualifications:

Education:

Ph.D. in medicine related field is prefferred

Other Skills:

1. Be familiar with drug research and development process;
2. Be familiar with Drug Administration Law, New Drug Approval, Drug Registration Regulation, ICH, GCP, the whole process of clinical trial and the current status and development trend of the clinical trial at home and abroad;
3. Master the basics of computer, and have good skills in office software.

Requirements:

1. Strong written and oral presentation skills, good at communicating;
2. Excellent collaboration in a cross functional team setting;
3. The ability to independently consult relevant literature and write reports;
4. The ability to work individually, the collective consciousness with strong team spirit;
5. Strong problem-solving ability, good at managing emergency plan;
6. Good adaptability with the ability to work under reasonable pressure;
7. Have strong sense of time, manage time reasonably and complete the work on schedule;
8. Pay attention to work details and be patient on work.

Location: Shanghai/Beijing

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