•按照既定研发计划和方案，负责临床试验的实施开展，确保试验在合理的预算和时间内完成，并符合相应质量要求。
•Responsible for the delivery of an agreed trial as defined in the trial outline/protocol and operational plan, to the agreed quality, budget and timelines.
协助 IND/NDA申报所需的各项临床研究计划制定、实施和数据准备和申报工作。
支持与监管部门各项沟通工作。
•参与临床试验方案和相关文件的制定或审核。
•Development or review of specific sections of the protocol and related documents.
•负责临床试验管理计划的制定和执行。
•Development of study management plans, and oversight of its implementation。
•参与项目外部合作方（CRO、SMO、研究机构等）的筛选、议价、合同草拟，付款等流程。
•Responsible for third party (i.e. CRO、SMO、Institution) selection，negotiation，agreement and payment process.
•日常管理外部合作方，监督试验进展和质量，协调资源，解决项目执行过程问题，确保按期完成目标。
•Day to day management of third party performance; Oversight of trial pace and quality; Coordination of resources to resolve the issues, ensure the target met as plan.
•掌握项目相关所有问题，及时汇报研究中出现的偏差，提供客观解释及可能接解决方案建议。
•Acting as point of contact for all trial-related issues/questions, escalate the issues/deviations in time, and provide objective interpretation and reasonable suggestions.
•按试验需求，拜访研究中心或开展质量控制访视。
•Perform quality control visits or booster visits as required.
•跨部门的协作和沟通，如医学，供应链等，
•Cross function collaboration and communication，including medical, drug supply management and so on.
•协助 IND/NDA申报所需的各项临床研究计划制定、实施和数据准备。
•Support IND/NDA dossier preparation in clinical section, like clinical development plan, trial related data.
•上级安排的其他相关工作。
•Other tasks per line manager required.
