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a) Assist in preparation of Data Entry guidelines for selected project
协助为指定项目编写数据录入指南
b) Understand and follow the Data Management Plan (DMP) with regards to project specific activities related to their function. Perform data entry from CRFs into the clinical database as required, Test data entry screens per data entry guidelines and Case Report Forms (CRFs) for selected projects.
理解并按照数据管理计划进行数据管理工作。对指定项目,根据录入指南要求对相应数据进行录入,对病例报告表界面进行录入测试。
c) Implement DMP changes to daily work activities, reference data issues log to resolve queries whenever possible, generate data queries as directed by the Data Management lead; conduct quality control processes including Case Report Forms (CRFs) to database review
及时根据DMP的改变做出相应符合数据管理工作的调整。解决日常的质疑,参考并记录数据问题追踪记录。在DML的指导下发出数据质疑。对数据病例报告表和数据库进行QC工作。
d) Independently perform data cleaning including query activity and Electronic Data Capture (EDC) reconciliation. Identify and report issues and data trends. Communication with regards to issues and concerns along with suggested resolution. Completion of assigned tasks in a timely manner meeting assigned goals for tasks. Run reports as requested and needed for daily tasks
能够独立进行数据清理工作,例如发出和解决质疑、发现和报告数据相关问题、产生数据报表或趋势表。沟通和解决发现的数据相关问题。及时完成项目分配的数据管理任务,参加指定的会议。根据内外部需求和自己日常工作的需要生成数据报表。
e) Reconcile project files, reports, listings and other documents generated in data management against the EDC database for accuracy and completeness of data management processes
对数据管理相关的必要的文档和电子数据库数据进行比对,保证数据的准确性和完整性。
f) Perform all tasks to relevant PPC and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management
从事所有本公司、客户、或者其它法规机构标准操作流程或指南所规定的数据管理相关工作。
g) Perform other duties as required by the Department
从事数据部门需要的其它工作
h) Act as DBP if needed
在需要的时候从事数据库程序员的工作
任职要求:
a) BSc degree in biological science or a related discipline in the science/healthcare field or equivalent education
生命科学或相关专业本科或以上学历
b) Basic knowledge in all technical elements of Data Management
对临床数据管理工作基础知识有所了解
c) Skilled in Microsoft applications
熟悉微软如Office办公软件
d) Basic understanding of medical terminology and clinical research terminology
熟悉和理解医学或临床研究相关术语
e) Communicates effectively through both written and verbal methods
良好的口头和书面沟通能力
f) Understanding of ICH-GCP principles
了解GCP的相关要求
g) Manages time effectively in order to produce quality deliverables in expected timeframe
有效的安排和管理时间,在要求的时间内完成各项任务