高知特信息技术(上海)有限公司 高知特信息技术(上海)有限公司人力资源部
Tel: ( 86 21) 61006466-69064
Mail: Sandra.zhang@
Position: Data management Specialist 数据管理员
ROLE: Perform assigned data management activities and handles inquiries from Medical Representatives/Doctors.完成指派的数据管理任务以及处理来自医药代表和医生的询问。
Time for onboard: December 2009
Resource needed: 5
REPORTING TO: Team Lead - Data Management汇报给数据管理团队负责人
ESSENTIAL QUALIFICATION:
? Graduate/Post Graduate degree with Life science/Pharmacy background (Microbiology/ Genetics/ Biotech/ Pharma/ Biochem/ Botany, etc)生命科学/药学背景（包括微生物学/遗传学/生物技术/药学/生物化学/植物学等）的本科/硕士学位
? Proficient in spoken and written Japanese with good voice quality and communication skills.流利的日语口语和优秀的日语书面表达能力，包括良好的发音和沟通技巧
ESSENTIAL SKILLS/PERSONALITY TRAITS:
? Overall knowledge of Clinical Research全面的临床研究的知识
? Good Clinical Practice (Knowledge of GPSP would be a plus)药物临床试验质量管理规范的知识（最好具备上市后调查管理规范的知识）
? ICH and Regulatory activities 国际协调会议药物临床试验质量管理规范以及药物申报的知识
? Overall knowledge of different therapeutic areas.各种治疗领域的知识
? Knowledge of drug development process药物研发的知识
OPERATIONAL RESPONSIBILITY:
? Review and action queries on an ongoing basis and update database based on the query resolutions.
? 对再调查依赖表进行日常的检阅及处理，根据再调查依赖表的回答来更新数据库
? Respond to inquiries from MR/Dr ongoing.
? 处理来自医药代表和医生的问题
? Create and maintain study CRF data standard document
? 生成和维护项目调查票的数据标准文件
? Create and maintain project and study Data Entry Instructions.
? 生成和维护项目数据录入指导书
? Maintain Data Management related operational data flows.
? 维护数据管理相关的操作流程
? Review reports and take actions as defined in the DMP or eCRF review manual
? 检阅各种报告以及根据数据管理计划书或者调查票检阅标准采取相应的活动
? Provide listings for review to the Client as per the timelines defined in the DMP and handle discrepancies found from reviews
? 根据数据管理计划书提供给客户各种列表，解决列表检阅后的错误
? Perform ongoing and final consistency checks And status reports
? 完成定期以及最终的一致性检查和状态报告
? Perform AE Reconciliation and query where necessary.
? 完成有害事件的一致性检查以及根据需要提出再调查依赖表
? Perform coding activities and raise queries where necessary.
? 完成对药物以及有害事件等单词的编码以及根据需要提出再调查依赖表
? Document agreed discrepancies that cannot be resolved in Study Master File before clean file declaration.
? 在宣布数据库整理完整之前，把无法解决的错误记录在SMF
? Support Quality control checks for the trail.
? 对质量管理的检查提供支持
? Ensure delivery of quality outputs.
? 确保高质量地完成任务
ADDITIONAL RESPONSIBILITY:
? Participate in knowledge sharing sessions as an when applicable.积极参与团队中的知识分享
? Ensure adherence to Cognizant and Client SOPs确保遵守高知特以及客户的操作规范
? Ensure timely submission of timesheets/ functional tracking spreadsheets确保及时地提交时间管理表以及活动跟踪表
Address:
8F, Building 5 Zhangjiang Semiconductor Industrial Park Shanghai,3000 Long Dong Boulevard Shanghai, Pudong
浦东龙东大道3000号
张江集电港5号楼8楼
高知特信息技术（上海）有限公司
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