1.全面负责策划、实施、运营、管理临床试验工作；
Responsible for the planning, implementation, operation and management of clinical trials;
2.与研究中心和研究者建立并保持良好的合作关系，根据公司业务发展需要，发掘并拓展合作医院和研究者；
Establish and maintain a good cooperative relationship with clinical centers and PIs, and explore and expand cooperative hospitals and PIs according to the company's development needs;
3.跟踪、检查项目各阶段的完成情况，追踪试验的执行情况，及时发现并解决问题，确保临床试验质量和进度；
Follow up the completion of each stage of the project, track the implementation of the clinical trials, find and solve problems in time, and ensure the quality and progress of the clinical trial;
4.管理临床监查团队，负责团队的建设与培养；
Managed the CRA team，be responsible for the construction and training of the team;

5.持续跟踪 NMPA，FDA, EMA等相关政策法规更新，确保临床试验严格按照法规、ICH-GCP 和SOPs进行，并按照设定的计划和质量要求完成临床试验；
Follow up the updates of relevant policies and regulations such as NMPA, FDA and EMA, ensure that clinical trials are conducted in strict accordance with regulations, ICH-GCP and SOPs, and complete clinical trials in accordance with the plans and quality requirements；
6.负责项目开展过程中第三方供应商的管理 （如：CRO，SMO，中心实验室等）；
Responsible for the management of third-party suppliers during the project implementation （such as CRO, SMO, Central lab，etc）
7.负责临床研究中心的评价与筛选、临床合同洽谈与管理；
Responsible for the evaluation and selection of clinical center, clinical contract negotiation and management；
8.负责团队成员的日常管理，合理安排员工的工作，定期与员工交流并评估员工的工作绩效；以及有效部门团队建设等；
Responsible for management of team members, arrangement of employees' work, regular communication with employees and evaluation of their work performance; effective department team building, etc.
9.及时向公司领导（CMO,CEO）反馈项目、人员的情况及遇到的问题并提出解决方案。
Timely feedback to the CMO, CEO about the project, personnel and problems encountered and propose solutions.
任职要求：
Job Requirements:
1.临床医学或药学相关专业本科及以上学历；
Bachelor's degree or above in clinical medicine or pharmacy related majors;
2.15年以上药物开发临床运营相关工作经验，熟悉肿瘤治疗现状及发展趋势，在肿瘤领域（尤其是瘤内给药）经验丰富者优先考虑；
15+ years of experience in drug development clinical operation related work, familiar with the current status and development trend of oncotherapy, experience in oncology field (especially intratumoral drug delivery) is preferred;
3.熟悉ICH指南、FDA、NMPA临床试验相关的各类法规和指导原则；
Strong knowledge of ICH guidelines, FDA, NMPA clinical trial related regulations and guidelines;
4.工作严谨，良好的项目管理经验；优秀的领导能力，沟通能力、抗压能力和团队合作能力。
Rigorous work, good project management experience; excellent leadership skills, communication skills, stress tolerance and teamwork ability.
5.英语交流能力、读写能力强。
Good English communication skills, reading and writing skills.