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liuchongyu铜虫 (小有名气)
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给虫友发福利了，辉瑞制药中国研究开发有限公司内部招聘职位Data Manager（武汉）
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职位名称/Position Title Data Manager (40 vacancies) 部门/Department CDS, WRDC 汇报人/Reporting to Vacant, CDS Group Lead, WRDC 工作城市/Location Wuhan 截止日期/Deadline August 20,2012 责任 辉瑞（武汉）研发中心向社会公开招聘临床数据管理员40名（工作地点：武汉） （如果您符合以下任一要求，并有兴趣在生物制药行业全球领先的辉瑞公司武汉研发中心 开拓职业发展机会的话，欢迎您第一时间申请我们的岗位）我们希望符合以下条件之一的 投寄简历。 1. 现在已经是临床数据管理员，或从事临床研究工作； 2. 具有医学，药学，或相关的学历（如护理，公共卫生等） 3. 现在的工作和背景能胜任临床数据管理员。 数据管理员的工作语言是英语，主要职能是： 1. CRF（Case report form）设计和使用数据库及系统 2. Data Management Plan (DMP) 制定 3. 负责收入的临床研究数据清理和提供报表 4. 临床研究档案管理 Position Purpose • The Data Manager is responsible for ensuring the completeness, quality and integrity of the subject data stored within the clinical trial database. • The Data Manager is responsible for data cleaning aspects of the data management role within a clinical trial, according to Pfizer Standards, Proces ses and Standard Operating Procedures (SOPs). • The Data Manager works with the global study team to meet the study ob jectives in the release of databases. • The Data Manager will ensure the consistent use and application of sta ndards. The ultimate objective is to ensure data quality and consistency acro ss programs and repositories. Organizational Relationships: • Directly reporting relationship to DM TA Lead or Team Lead in CDS • Strong partnerships with Lead Data Managers (LDM), Project Data Manage ment Leads (PDL), and Data Base Managers (DBM) within Pfizer • Partnership with other related functions in study teams as needed. Resources Managed (budget and FTEs): NA Primary Duties: General • Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements. • Ensures Conformance to Pfizer Data Standards or designated data standa rds. • Actively participates in monthly project review meetings. Specific: • Create the Data Management Plan (DMP) for completeness and accuracy, i ncluding the Data Flow Activities Document, CRF Completion Guidelines, Data Qu ality Specification (Edit checks), Data Listing Documents, Data Handling Conve ntions (Permissible Changes), Data Quality Control Plan and Data Entry Guideli nes. • Set-up and test data review listings to verify the quality and complet eness of data as specified in the Data Quality Specification (Edit checks) doc ument. • Ensure timely set-up of clinical data acquisition and management tools and data validation. • Maintain a Study Tracking Spreadsheet to track the progress of CRF ret rieval, data entry of CRFs and data cleaning activities. • Perform data cleaning activities including discrepancy management (rev iew of errors from electronic checks) and review of data listings to verify qu ality and completeness of data and issue Data Clarification Forms (DCFs) as ne cessary to seek further clarification from sites. • Ensure integrity of clinical data and update database with resolved DC Fs as necessary. • Reconcile the Serious Adverse Event (SAE) data between patient databas e and the safety database. • Document all efforts in the cleaning and release of the database. • Ensure filing of all clinical trial documentation to the Trial Master File. Training & Education Preferred: • Bachelor’s degree or equivalent in a natural/medical science, data ma nagement or related discipline. • Fluent English both in reading and writing. Prior Experience Preferred • Working knowledge of clinical development process, understanding conce pts of Phase I-IV and principles of study design. • Previous experience within a data management role, understanding key p rocesses and principles associated with role including CRF design, database se t-up, edit check specification, DMP and data cleaning activities. • Knowledge of Windows Environment and its applications (Word, Excel and PowerPoint, Project, etc.). 请投递中英文简历，简历投递邮箱：pfizerhr@sina.cn [ Last edited by liuchongyu on 2012-8-16 at 21:34 ] |
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zy120418
木虫 (著名写手)
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