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

其他信息
语言要求：英语、普通话