岗位职责：
1.确保所有临床运营活动符合监管部门法规, GCP及公司SOP的要求, 确保临床试验项目的开展的合规性。
Ensure execution of clinical studies in adherence to regulations，GCP and SOP. In addition, ensure clinical trials are executed within compliance policy.
2.对直线下属提供包括指定目标， 绩效考核和人才发展等方面的管理，确保员工按照部门培训课程表完成相应的入职培训以及常规培训，监督下属及时完成内部规定或SOP的更新学习，根据业务需求进行新员工的招聘，进行人员保留等管理工作。
Provide management for study managers, including setting goals, performance assessment, and employees development, to ensure that employees complete the corresponding onboard training and regular training in accordance with the departmental training schedule, supervise subordinates to update and learn internal regulations or SOPs in a timely manner, conduct new staff hiring, maintaining and other management work.
3.监督下属并提供指导，进行常规人员管理的工作，OA系统审阅及批准。
Supervise and provide guidance, conduct routine personnel management work，review and approve the OA system.
4.监督，指导下属与当地/总部或跨部门沟通研究时遇到的问题，帮助下属识别潜在风险，督促下属及时应对第一三共内部稽查和外部核查，以促进争议问题的解决。
Supervise and guide direct reports to communicate the encountered study problems with local/global or cross-functions, help to identify potential risks, and urge them to respond promptly to Daiichi Sankyo's internal audits or external inspection, resolve the controversial issues promptly.
5.监督临床运营经理对项目进展的质量控制。采取及时有效的措施，确保人员离职或长假不影响研究质量，研究交接能够平稳过渡。
Supervise quality control of project progress by the clinical operations manager. Take timely and effective measures to ensure study quality is not affected by personnel departure or long leave, ensure study handover can be complete smoothly without quality affective.
6.通过不同形式的会议（临床部例会、科内例会和常规1 on 1会议） 促进成员之间的信息交流。
Promote information exchange among members through various forms of meetings (CO departmental regular meetings and section internal regular meetings and one on one meetings).
7.从临床运营角度对于将要在中国开展的新产品开发的策略给与一定的建议
Provide insight from CO perspective, provide insight for the strategy of new product development to be carried out in China.
8.负责全面的掌握并监督研究层面的主要信息（ 包括研究的期限，预算，风险评估，主要相关方的识别与沟通等）
Be responsible for comprehensively grasping and supervising the main information at the research level (including the research period, budget, risk assessment, identification and communication of major stakeholders, etc.)
9.作为临床运营部代表，负责全球临床试验项目的推进与交付。监督试验执行过程中的可行性评估，研究中心的筛选与启动， 患者入组，数据收集， 试验质量的监督等关键环节。
As the representative of the Clinical Operations Department, accountable for the progress and delivery of global clinical trial projects. Supervise the trial execution process, such as feasibility assessment, selecting and initiation of the research center, patient’s enrollment, data collection, and supervision of trial quality.
10.监督供应商（ 如CRO， SMO等） 在中国本土的筛选， 评估和选定流程， 确保所有供应商在中国开展的研究相关活动符合研究时限，质量要求以及中国法规规定。 监督并参与对供应商的绩效评估并反馈给研究团队。
Supervise the screening, evaluation and selection processes of vendors (CROs, SMOs, etc.) in China to ensure that all research-related activities conducted by vendors comply with required timeline, meet quality requirements and Chinese regulations. Supervise and participate in the performance evaluation of vendors and provide feedback to the study teams.
11.协助管理部门预算以及监督各项目的预算，确保成本与效益，监督临床试验在预算范围内按时完成。
Assist in managing department's budget and oversight the budgets of various projects to ensure cost and benefit. Supervise the timely completion of clinical trials within the budget.
12.协助临床运营部门负责人制定临床运营的策略与年度计划，传达明确的运营目标，优化、完善临床运营相关的SOP与流程。
Support CO head to generate department annual plans and goals, cascading the clarified operational goals, and optimizing and improving SOPs and processes related to clinical operations.
13.支持第一三共中国开发总部的相关活动 协调临床运营团队与其他跨部门团队，以及相关方的工作，确保高效协同。
Support the relevant activities of the Development Department of Daiichi Sankyo China. Coordinate the work of the clinical operation team with other cross-functions and related stakeholders, to ensure efficient collaboration.
14.对接研究中心，外部供应商，第一三共中国，以及公司总部等，建立并加强与跨部门以及内外部的沟通， 建立并维护良好合作关系，协助解决沟通合作问题。
Connect with sites, vendors, DSCN, and global, etc. Establish and enhance the communication, maintain good cooperative relationships with internal and external relevant stakeholders and assist in resolving communication and cooperation issues.
资历要求：
1.医药相关专业本科及以上学历， 医生或药师优先考虑。
Bachelor's degree or above in medical-related fields. Doctors or pharmacists are preferred.
2.至少8年制药行业经验或者CRO临床运营经验， 包括至少4年的项目管理经验，制药公司经验优先
At least 8 years of experience in the pharmaceutical industry or CRO clinical operation, including at least 4 years of project management experience. Experience in pharmaceutical companies is preferred.
3.熟悉以注册为目的的1-4期试验的流程
Be familiar with the process of Phase 1-4 trials for registration purposes.
4.既往有跨部门项目管理经验
Have experience in cross-departmental project management.
5.有外包项目管理经验以及人员管理经验者优先考虑
Have experience in outsourcing project management and personnel management is preferred.
6.良好的英文听说读写能力
Excellent English listening, speaking, reading and writing skills.
7.具有良好的组织能力-能够在复杂的要求和监督过程中区分优先级
Excellent organizational skills - capable of prioritizing complex requirements and supervision processes.
8.良好的团队协作者-有效的和同事进行合作
Good team collaborator - effectively cooperate with colleagues.
9.出色的沟通能力-可以跨文化与总部同事顺畅的沟通
Outstanding communication skills - capable of communicating smoothly with colleagues at the headquarters across cultures.
10.具有领导力，能够在必要关键时做出决策的能力
Possessing leadership and the ability to make decisions when necessary and crucial.
11.优良的解决问题的能力
Excellent problem-solving skills.
12.能熟练应用办公软件用于项目管理
Proficient in using Microsoft office software for project management.