Clinical Research Physician - Oncology [Medical]
• 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.
≥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.
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