MA Manager (MJ001252)-全国-非肿瘤

该职位来源于猎聘 非肿瘤方向 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