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Participate in all stages of the clinical trial development process including: feasibility assessments;protocol design; CRF design; investigational site selection; generation of clinical study reports
? Acts as Medical Monitor / Advisor for assigned trials or programmes
? Exhibit and transmit the highest ethical standards in the management of clinical trial programs and client liaison
? Provide medical support to the clinical project teams
? Provide therapeutic area training to the clinical project teams and investigator teams
? Take responsibility for the medical management of adverse events and serious adverse events in accordance with project related guidance
? Review SAE narratives and takes responsibility for the writing of narratives associated with critical events as defined by each project
? Oversee medical aspects of the risk management and risk mitigation strategies
? Supports Pharmacovigilance is relevant steps of case processing and periodic reporting
? Provide medical input to relevant Pharmacovigilance activities throughout the product lifecycle
? Take responsibility for and initiates the medical review of: protocols; CRFs; adverse events; clinical study reports; data management and statistical tables and listings; audit reports
? Write assigned sections of clinical study reports
? Post graduate medical qualifications with a licence to practice medicine in china
? Ideally qualified with Master in clinical medicine
? 3 or more years of practising clinical medicine
? 3 or more years of clinical research/development experience within a pharmaceutical or biotechnology company or clinical research organisation
? Comprehensive knowledge of the clinical development process and its critical paths
? Extensive knowledge of ICH GCP, China GCP
? Awareness of China regulatory and pharmacovigilance environments
? Experience of a wide breadth of therapeutic areas