• Develop appropriate programme profiles and programmes to support research recommendations and meet local registration requirements, and provide disease and programme training to CTA/CRC.
• Develop local ICF (informed consent document) and translate as required.
• Prepare and deliver product and program presentations at the investigator's meeting and answer questions from the investigator.
• Act as clinical director in the research team, review and approve subject eligibility and project deviation, review study medical data, analyze adverse events/serious adverse events and answer clinical and product inquiries from researchers.
• Provide input in the final determination of SAP (statistical analysis plan) and strive for database cleansing

• Prepare clinical documentation as needed to respond to CDE query.
• Prepare slides as needed and deliver presentations to the CDE review meeting for the clinical section

职能类别： 生物工程/生物制药