Perform study start-up activities, including study plan build-up, study protocol and CRF design, Investigator Meeting, EC and MOST approval, site selection, site initiation, E-Trial development, co-monitoring, study closure and other related activities ensuring compliance with NMPA regulation, GCP/ICH guidelines and company SOPs.
Allocate the budget by project and conduct the daily management and update the usage status.
Document and updated the progress of assigned clinical studies through regular status report.
Provide direction and oversight of outsourced activities to ensure Clinical Research Organization (CRO) and vendors delivery against contracted scope of work.
Bachelor or master in medical.
8 years clinical research experience, 5 years people management experience.
Open minded, Able to work under pressure, Strong organizational, communication skill, high degree of accuracy and attention to detail.
Collaborate with cross functional department such as Global Medical Science Affairs, Regulatory Affair, Sales & Marketing, IT, Finance and Legal to support project milestone achievement. Provide clinical Trial dossier for registration use.
Coordinate Medical Affairs tasks such as Post Marketing clinical Projects, clinical Evaluation Report, publication. D1520.
Fluent in English.