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本人受公司委托不能在论坛里直接说出客户名字，希望各位站友理解。
委托公司是一家全球500强，纳斯达克上市美资公司，目前在上海招聘临床数据管理（对日）若干人，日语好刚毕业无经验也是可以的。生物统计师（对欧美）若干人，最好4年以上工作经验英语好就行。
各位站友有兴趣的可以发简历给我，一定回复。有任何问题，也可以联系我，最好邮件中留有联系方式方便联系。
邮箱地址：luofu@bwhr.net
Clinical Data Management Associate_临床数据管理专员(要求日语)
• 生命科学或医药本科学位或以上
• 良好的日语沟通（口语及书面）能力（日语1级）
• 熟悉临床试验的全过程
• 熟悉GCP(药品临床试验管理规范)知识，具备GPSP知识为佳
• 熟悉ICH(人用药物注册技术要求国际协调会) 及相关的法规
• 具备各种治疗领域相关知识
• 了解药物研究流程
JOB ROLE
Key Accountabilities (Technical)
• 进行病例报告表数据的日常检阅以及质疑表的处理
• 应对医药代表以及医生的 咨询
• 制作并维护临床试验数据相关的各种文件
• 制作并维护项目相关的数据录入标准
• 执行并维护数据管理相关的操作流程
• 检阅各种报表以及 依据数据管理计划书或eCRF检阅标准进行各项操作
• 依据数据管理计划书中所规定的期限向客户提供各种列表以及通过对数据的检查解决所有发现的不一致性
• 定期完成一致性检查报告和进展报告
• 完成不良事件一致性检查并根据需要完成质疑表
• 完成医学编码并根据需要完成质疑表
• 在数据锁定之前将无法解决的问题记录在相关文件上
• 对质量控制提供支持以备稽查
• 确保最终产品的质量.
Biostatistics (Statistician)_生物统计员(要求英语)
Minimum Requirements -Education and Experience
• University degree in Statistics, Mathematical Statistics or Biostatistics, or equivalent experience.
• Comprehensive knowledge of Clinical Drug Development processes and ability to and ensure compliance with regulatory authorities, quality and technical standards.
• 3-10 years of statistical experience with Global pharmaceutical companies, Clinical Research Organisations, or Business Process Outsourcing companies.
• Computer programming aptitude
• Good knowledge of spoken and written English.
• Good communication and presentation skills
• Demonstrated ability to work collaboratively in a team environment as well as independently.
• Demonstrated ability to manage own priorities and goals.
Business and Functional Knowledge
• Comprehensive knowledge of clinical and pharmaceutical drug development process and associated Good Clinical Practice (GCP).
• Awareness of regulatory requirements e.g. Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines.
• Multi-phase experience in Clinical research ( phase 2, phase 3, phase 4) in a variety of study complexities.
• Experience of different Therapeutic Areas (Oncology, CV\GI, Respiratory, Neurosciences, Infection).
Programming and statistics
• SAS programming knowledge.
• S-plus programming knowledge.
• Knowledge of randomization technique.
• Knowledge of statistical modelling corresponding to advanced level.
• Knowledge of the end to end process involved with Analysis and Reporting
• Analytical skills:
o Ability to turn objectives into relevant statistical analyses
o Understanding how to present data and analyses to simplify the interpretation for the customer
o Ability to turn analysis needs into data structures
o Ability to draw statistical conclusions from results
o Ability to check assumptions and appropriateness of pre-specified statistical methods and presentation and to suggest relevant changes or additions
• Communication skills
o Be able to present and explain results to other subject matter experts
o Be able to contribute with statistical input to documents such as a clinical study protocol or a clinical study report.
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发表于 2011-12-28 09:41:30