• Primary deliverables of role; it's scope; impact on strategy, policy, business or people relationships
• Provide medical input into clinical studies involving China
• 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
• Perform medical monitoring for the studies in charge
• Assist with study operation team in coordinate with 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 statistical analysis plan finalization and efforts in achieving batabase clean
• Prepare and finalize local clinical study report, and assist study result publication
• Provide medical support to deliver regulatory submissions(IND and NDA, etc)
• Relevant medical document preparation
• Support communication with regulatory agency(including panel meetings, etc) and relevant material preparation
• Ensure governance across all clinical activities
• Ensure a high level of self directed understanding, dissemination and teaching of the GSK policies and SOPs
• Ensure the safe and ethical conduct of trials
• Medical governance of activities before asset launch in China under scientific engagement principles
• Perform as project leader to be accountable for China development strategy for early stage compound in Specialty Care.
Why You?Basic qualifications:
≥2 years hospital physician experience
• ≥1 years industry clinical research experience, or ≥2 years industry medical affairs physician experience.
• Minimum Master degree in clinical medicine
• Knowledge of clinical development process and GCP
• Interpersonal communication skill;
• Excellent written/verbal communication skills in English
• Basic knowledge of Project Management
• Knowledge of and regulatory requirements
• Knowledge of PC (WORD, EXCEL, POWERPOINT);
• Presentation skill. *LI-GSK
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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