MA Manager/医学经理-肿瘤 (MJ001259)-全国

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