1.Provide overall project management, in both the technical and the administrative aspects, of clinical projects in a timely and effective manner and in accordance with GCP. 根据GCP,及时有效地在技术和管理方面对临床研究项目进行全面的项目管理。 2.General responsibilities include: trial project assessment and initiation, resource purchase and planning, project executing, leading and motivating the team, milestone planning and tracking, ensuring that the project is executed in accordance with quality standards, SOPs, fulfillment of local regulations, preparation of key project progress reports, overseeing the work of the team, as well as clinical trial contract and financial management. 一般责任包括:试验项目评估和启动、资源采购和规划、项目实施、领导和激励团队、里程碑规划和跟踪,确保项目按照质量标准、标准操作程序执行,履行当地法规,编制关键项目进度报告,监督团队工作,以及临床试验合同和财务管理。 3.Guidance of PM/APM 指导PM/APM
职位要求: 1.A bachelor degree (or above) in a life science (preferably paramedical) field. 临床医学/药理学/护理学/卫生管理或其他医药相关专业的本科或以上学位。 2.At least 5 years’ work experience, with at least 1 year’s experience in clinical study management 五年以上的临床研究经验,其中至少一年的项目管理经验。 3.More than three years of project management experience or experience in clinical trials in the field of respiratory diseases is preferred. 三年以上项目管理经验或有呼吸系统疾病领域临床试验经验者优先。 4.Proficiency in both listening and speaking English. 有良好的英文听说能力。 5.Demonstrate understanding of or ability to learn and demonstrate understanding of SOPs relevant regulations e.g. ICH/GCP, Clinical trial guidelines). 展示对标准操作规程和相关法规(如ICH/GCP、临床试验指南)的理解和理解能力。 6.Demonstrated understanding of project management workflow process, and roles and responsibilities of multiple functional areas. 理解项目管理工作流程,以及各职能部门的角色和职责。 7.Demonstrated ability better to understand, explain and communicate projects. 表现出更好地理解、解释和沟通项目的能力。 8.Ability to coach PM/APM. 能够胜任指导PM/APM工作。 9.Strong organizational, interpersonal, and self-motivational skills, as well as high standards of professional ethics and personal integrity. 具有较强的组织能力、人际交往能力、自我激励能力,以及高标准的职业道德和个人诚信。