Clinical Research Physician [Medical]
• primary deliverables of role; it's scope; impact on strategy, policy, business or people relationships
1. 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
2. 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
3. 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
4. Perform as project leader to be accountable for China development strategy for early stage compound in Specialty Care.
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