Clinical Research Physician, Immunology

Major Responsibilities：

• Ensure all clinical studies operate to the highest level of ethical and safety standards and in compliance with GCP, SOPs and regulatory requirements
• Develop appropriate protocol synopsis and protocols to support research proposals and meet local registration need
• Actively participate feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback.
• Translate final protocols and amendments for global/regional studies
• Assist with study operation team in Coordinating Principal Investigator and leading site selection
• Prepare and deliver presentations for product and protocol introduction at investigator meetings and trainings to study team
• Act as protocol and clinical lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators
• Provide valuable inputs in SAP (statistical analysis plan) finalization and efforts in achieving Database clean
• Prepare and finalize local clinical study report, and assist NDA submission.
• Maintain high level of clinical understanding of GSK products and assigned disease area, provide knowledge training to study team as needed
• Establish and Maintain an effective network of relationships with key opinion leaders in assigned disease area

Requirement：

• Minimum master degree in clinical medicine
• Knowledge of clinical development process, and regulatory requirements
• At least 3 years experience in medical practice of rheumatology and 1-2 years experience in industry medical team, including the clinical study management, protocol/study report writing.etc
• Good command of English (written and spoken);
• Knowledge of PC (WORD, EXCEL, POWERPOINT);
• Interpersonal communication skill;
• Team player
• Presentation skill
• Project Management
• Leadership and people management