Responsibilities

• Make clinical development plan and complete clinical trial protocol design
• 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
• Solve medical problems and analyze data related to medicine in clinical study. Make sure the clinical study conform to clinical trial protocol, ICH, GCP and company SOP
• Engage with clinical specialists and drug regulatory authorities on clinical study design and development strategies and so on

Qualifications

• Education: M.D, or MBBS
• Language Requirement: Professional working proficiency in English

Required Skills

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

Preferred Skills

• Be familiar with drug research and development process
• 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
• Master the basics of computer, and have good skills in office software

Location: Shanghai/Beijing