Sr Clinical Manager

Job Responsibility：

• 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.
• Understanding GCP.
• Fluent in English.