临床项目高级经理/经理 PM/SPM

该职位来源于猎聘 岗位职责Job responsibility: 1. 负责临床试验项目开展和执行，遵循适用法规，按计划、预算，高质量完成，确保临床试验过程及结果满足适用法规部门要求 Responsible for the execution of assigned project, project deliverables with high quality according to timeline, endorsed budget and applicable regulations and guidelines, and ensure the conduct and result of clinical trial to meet the requirements of applicable regulatory departments. 2.作为临床试验项目团队的管理协调者，组织协调项目团队各个部门成员，制定确认临床试验项目相关计划及项目预算，监督项目执行，保证临床试验项目按时高质量完成 As a key coordinator of the project team, organize and coordinate project team members across various departments, develop and confirm relevant project plans and budgets, provide oversight of project execution, and ensure timely and high-quality deliverables per timeline. 3.作为临床试验项目的主要联系人，负责内部和外部沟通及协调，及时更新临床试验项目进展或/和相关问题报告及解决 As the key contact point of the project, responsible for internal and external communication and coordination, timely updating the progress of the clinical trial project and/or related problem reporting and solutions. 4.带领临床试验团队完成临床试验中心可行性、临床试验中心筛选、临床试验中心项目启动、受试者招募、数据清理及锁库、临床试验中心关闭等相关工作 Provide leadership to the project team to perform clinical trial feasibility, clinical trial site selection, site initiation, enrollment, data management and database lock, as well as closeout etc. 5.负责临床试验项目供应商（CRO、SMO、中心实验室、临床试验物资管理、试者招募等）筛选及管理 Responsible for vendor selection and management for the project, including CRO, SMO, central laboratory, drug and non-drug supply, subject recruitment, etc. 6.负责临床试验文件（包括但不限于临床试验必备文件）收集、更新、保存满足GCP和适用法规的要求 Responsible for collection, update, and archive of clinical trial documents (including but not limited to essential documents) to satisfy the requirements of GCP and applicable regulations. 7.完成上级领导安排的其他工作。 Complete other tasks assigned by superiors. 任职资格Qualification 1.本科及以上学历，生命科学、药学、护理学等相关专业。 Bachelor's degree or above, in life sciences, pharmacy, nursing, etc. 2.熟悉和掌握药品临床试验相关法规及GCP等相关规定。 Familiar with and full knowledgeable in the relevant regulations of clinical trials and GCP and other applicable guidelines. 3.有1-5年临床试验项目管理经验及医药行业相关工作经验，熟悉临床试验常用系统（如：EDC、eTMF）。 1-5 years of work experience in project management and the pharmaceutical industry, familiar with systems commonly used in clinical trials (e.g. EDC、eTMF) 4.英文口语书写阅读能力满足管理国外临床试验项目。 Capability of speaking, writing, and reading in English to meet the requirement for the project management outside of China. 5.团队合作精神，跨部门沟通协调管理能力。 Teamwork, ability in cross functional communication, collaboration and management. 6.自我学习能力和挑战能力。 Self-learning and challenge taking.