Data Management Leader(临床数据管理主管)

职位描述/Job Description

1.    Write/review/improve data management department SOPs. job guidance. and standard templates. etc. to ensure all work complies with internal and external quality standards. ICH-GCP. and/or other applicable domestic and foreign regulations, guidelines, and industry standards.

撰写/审阅/改进数据管理部门的SOPs、工作指导及标准模板等,确保所有工作符合内、外部的质量标准,ICH-GCP/或其他适用的国内外法规、指导原则和行业标准。

 

2.    Manage and supervise the daily work of the team, coordinate the resource allocation of the project, and manage the risk of the deliverables. Ensure all deliverables are delivered on time and in good quality.

管理和监督团队的日常工作,协调项目的资源分配,对可交付成果进行风险管理,确保所有交付成果按时按质交付。

 

3.    Acted as the project leader of one or more clinical trial data management, arranged project personnel, and evaluated the performance of team members.

担当一个或多个临床试验数据管理的项目负责人,安排项目人员,评估团队成员的绩效。

 

4.    Under the guidance of the data manager, acted as the project data manager for the clinical trials of low/medium complexity. Led the data team to complete the project within the timeline and budget, monitored project resources, project budget, and identified changes in work scope during the implementation of the project.

带领数据团队在时间表和预算内成功完成项目。项目实施过程中监控项目资源,项目预算,识别工作范围的变动。

 

5.    Provide technical support and training for the team.

为团队提供技术支持和培训。

 

任职资格/Qualifications

1.    Bachelor's degree or above, major in medicine, biochemistry, computer science, or English.

医药类、生物化学类、计算机、英语相关专业本科及以上学历。

 

2.    3-5years hands-on project experience, global project is preferred.1 year or above project team management experience is preferred.

3-5年数据管理项目经验,global项目经验或1年以上项目团队管理经验优先。

 

3.    Data management including but not limited to project management, case report form design, database design, logic check, data management plan and data cleaning, communication and coordination of the third party, etc.

具有数据管理工作经验,包括但不限于项目管理、病例报告表设计、数据库设计、逻辑检查、数据管理计划和数据清理、第三方的沟通协调等。

 

4.    Have a deep understanding of clinical trial related knowledge, industry standards for clinical trial data management (GCP, CDASH, GCDMP) and related NMPA/FDA regulations and guidelines.

深刻理解临床试验相关知识,临床试验数据管理的行业标准(GCPCDASHGCDMP)和相关的NMPA/FDA法规、指导原则。

 

5.    Fluent oral and written communication skills in both Chinese and English.

流利的中英文口语和书面交流沟通能力。

 

6.    Able to work with high accuracy, attention to detail, and strict quality control.

能够适应高度精确性、非常关注细节及严格质量控制的工作方式。

 

工作地点:上海—浦东张江地区/周浦地区

薪资待遇:面议

简历发至:HR@xihuasci.com(请注明应聘职位)




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