职位： 临床事务总监 Clinical operation director

1. 有海外工作、学习经历
2. 硕士其以上学历，5年以上相关工作经验
3. 3个月内到位

岗位职责： Responsibility：
Ø 确保临床实验项目依据相关标准、时间期限对资源进行筹备、管理、执行。 Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards；
Ø 负责协议合同的管理；准备合同、修订合同，准备临床实验项目要求的CRF，知情同意书，及其他文档。 Lead manager of protocols; prepares protocol, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial；
Ø 维护管理内部临床实验文件及文档。 Maintains and manages internal clinical trial files and documents ；
Ø 按要求准备注册文件，如年度报告，为签定合同的最终研究报告等。 Prepare required regulatory documents, such as annual reports, updating of the IB, and final study reports for assigned protocols；
Ø 负责临床事务管理。 Serve as clinical monitor ；
Ø 管理日常临床事务，包括对于供应商/外包商管理及协调。 Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities Ø 参与调研会议并跟踪。 Participates in investigator meetings and follow up；
Ø 协调计划临床供给、非临床供给有效性，以达到研究要求。 Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements；
Ø 必要时需要出差。 Travel to sites when necessary ；
Ø 保持与其他部门的及时沟通，以确保与临床实验项目相关的信息能有效沟通并保持双方良好关系。 Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects Ø 领导交给的其他工作。 Other duties as assigned 。

任职条件: Qualification:
Ø 临床事务总监应在医药行业有8年以上工作经验，至少5年直接负责管理计划临床实验项目的工作经验。 The Director, Clinical Operations should have a minimum of 8 years experience in the pharmaceutical industry, with minimum 5 years direct experience in planning and managing clinical trials.
Ø 候选人必须有扎实的医药临床实验的相关知识，并有临床实验管理经验。 The candidate must have solid understanding of pharmaceutical clinical development process and have experience with clinical monitoring.
Ø 候选人应有在临床实验一阶段和二阶段丰富的经验，并有直接管理经验。 The candidate should have significant experience with responsible roles in the conduct or management of Phase I and II clinical trials.
Ø 候选人具有博士或同等学历，医学或生物学领域更佳。 The candidate must have a PhD degree or equivalent; health science degree or biologic science degree is preferred.
Ø 候选人必须掌握医学术语、生理学术语、药理学术语。并且精通美国及国际规章制度。 The candidate must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines.
Ø 需要流利的口头及书面表达能力，组织计划能力及管理能力。 Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage budgets.
Ø 候选人要注重细节、主动做事，在快节奏小企业环境中能承担多项工作责任。The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.