长沙招聘

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
职能类别：
临床研究员
关键字：
医学监查

昆翎（ClinChoice）是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO，服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心，目前在全球拥有1800多名员工，其临床运营团队覆盖了亚、欧、北美等七个国家和地区。

高盛直投部董事总经理、昆翎董事会成员许小鸥先生认为，“随着创新疗法在全球的增长，CRO公司提供高效、可靠的研发服务能力变得尤其重要。昆翎独特的价值主张结合了其对于本地市场的了解、国际药物研发的经验以及高效的团队执行能力。我们坚信公司强劲的管理层团队以及其高效的执行能力，将为昆翎的发展开启新的篇章。

昆翎是一家全球化的临床合同研究组织 (“CRO”)，在亚洲、北美洲和欧洲七个不同国家和地区拥有超过1800名临床研究专业人员。在全新品牌战略的引领下，昆翎将以“立足中国，服务全球”为己任，继续为全球制药、生物科技和医疗器械公司提供高质量、全方位服务的临床研究服务