Responsibilities:

1.  研究团队制定的将要在中国开展的新产品开发的时间表从本地临床操作的方面给予一定的建议。

  Provide suggestions from local clinical operation perspective for the development schedule of new product created by the study team when executed in China.

2.  全面掌握研究层面的主要信息（包括研究的期限、预算、风险评估活动、主要相关方等）。

  Have a clear whole picture for the primary information in study level(including study timeline, budget, risk assessment and key stakeholders).

3.  熟悉所在科负责临床试验项目的预算的计划和实际使用情况。

  Familiar with the budget plan and actual status of the study in the charge of responsible section.

4.  对直接下属提供包括制定目标，绩效考核和人才发展等方面的管理。确保新进员工按照部门培训课程表的要求完成相应的入职培训，监督下属及时完成内部规定或者SOP更新的学习。

  Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development. Ensure the new comers will complete the orientation training according to department training curriculum. Monitor the direct reports to complete the self learning of update of internal regulations or SOPs.

5.  在第一三共中国开展或者支持的研究中监督下属并给下属提供指导，确保研究实施符合公司SOP和法规要求。

  Supervise direct reports and provide instruction to subordinators for studies conducted or supported by DS China. Ensure study is conducted according to requirement of company SOPs and regulations.

6.  指导下属与总部相关部门沟通研究遇到的问题和潜在的风险。

  Instruct the direct reports to negotiate occurred issues and potential risks with related function in DS headquarter.

7.  督促下属及时应对第一三共的内部稽查和外部视察以促进争议问题的解决。

  Oversight the direct reports to deal with Daiichi Sankyo internal audit and external inspections in time in order to facilitate conflict resolution.

8.  通过各种形式（比如科内例会和临床部例会）促进成员之间的信息交流。

  Prompt the internal information sharing between direct reports through different ways(such as internal section periodical meeting and clinical regular meeting).

9.  监督第三方供应商（CRO,SMO等）在中国本地的筛选、评估和选定等流程，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、要求以及中国法规规定。监督并参与对供应商（如CRO,SMO等）的绩效评估并反馈给研究团队。

  Oversee the screening, evaluation and selection process for China local 3rd party vendor (such as CRO, SMO), oversee the study related activities of third party vendors to ensure the adherence to study timeline, requirement and Chinese regulation. Oversee the quality of vendor service and be involved in vendor (such as CRO/SMO,etc.) performance evaluation, provide the feedback to the study team.

10. 和相关部门合作支持第一三共中国、开发总部的相关活动。

  Cooperate with relevant departments to support DSCN/DD activities.

11. 提前采取措施确保辞职或者长期休假出现时在研究层面和任务层面的平稳交接。

  Take proactively actions to ensure the handover process goes smoothly both in study level and task level when resignation or long term leave occurs.

Requirements:

医药相关专业本科或以上学历。

Bachelor Degree and above majored in Medicine, Pharmacy or related.

至少10年制药行业或者CRO临床试验的经验，包括至少6年的项目管理经验，制药公司经验优先。

At least 10 years’ experience in clinical research in pharmaceutical industry or CRO, and at least 6 years’ experience in project management, pharmaceutical experience is preferable.

熟悉以注册为目的的1-3期试验的流程。

Familiar with the process throughout the Phase I-III study for registration purpose.

既往有过跨职能部门或者项目工作经验。

Previous experience working in cross-functional teams or projects.

有外包项目管理经验以及人员管理经验者优先考虑。

Preferable to have outsourcing study management & people management experience.

英文听说读写熟练。

Fluent English listening, speaking, reading and writing skills.

良好的组织能力-为了完成项目能够在复杂的要求和监督过程中区分优先级。

Good organization ability-be able to prioritize conflicting demands and monitor progress toward the completion of the project.

良好的团队协作者-有效地和同事进行合作。

Good Team player-work effectively with staffs.

较好的沟通技巧-确保研究团队内部和跨职能沟通的有效性。

Good communication skills -ensure effective communication within study team and cross function communication.

展现出能够与总部同事进行跨文化沟通以及和第三方组织沟通的能力。

Demonstrated ability to work cross-culturally with global colleagues and with third party organizations.

良好地协作能力-能够有效组织研究团队讨论。

Good coordination ability-be a meeting facilitator to effective study team discussion.

熟知适用于临床试验的法规和指南。

Strong knowledge of regulations and guidelines that apply to conduct o clinical trials.