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负责多产品策略的portfolio管理及专业治疗领域的临床研发计划的制定与执行。涵盖特定疾病领域相关研究的策略方案、执行,对研究结果进行准确的分析及解读。并且兼顾团队人员能力的发展与管理。
承接公司总体战略方向,协助职能总监制定公司中长期发展策略规划(包括核心业务中长期发展策略与业务组合中长期发展策略);
作为战略与运营副总裁兼董事长助理,主要负责集团层面战略落地、运营提升、精益管理、业务流程优化等工作
In collaboration with the Medical Director, supports the development of study protocol and amendments, clinical sections of regulatory documents, including investigator brochures, annual safety update reports; contributes to study documents, including AE section of ICF templates, eCRFs and SAE report forms.
Perform site selection (If applicable )), initiation, monitoring and close out visits in accordance with contractedscope of work and good clinical practice. P erform study start up activities, including site EC submission,contract negotiation, etc. If applicable, Clinical Research Associates may be accountable for development ofproject subject recruitment plan on a per site basis.
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