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liuchongyu銅蟲 (小有名氣)
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給蟲友發(fā)福利了，輝瑞制藥中國研究開發(fā)有限公司內(nèi)部招聘職位Data Manager（武漢）
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職位名稱/Position Title Data Manager (40 vacancies) 部門/Department CDS, WRDC 匯報人/Reporting to Vacant, CDS Group Lead, WRDC 工作城市/Location Wuhan 截止日期/Deadline August 20,2012 責(zé)任 輝瑞（武漢）研發(fā)中心向社會公開招聘臨床數(shù)據(jù)管理員40名（工作地點：武漢） （如果您符合以下任一要求，并有興趣在生物制藥行業(yè)全球領(lǐng)先的輝瑞公司武漢研發(fā)中心 開拓職業(yè)發(fā)展機會的話，歡迎您第一時間申請我們的崗位）我們希望符合以下條件之一的 投寄簡歷。 1. 現(xiàn)在已經(jīng)是臨床數(shù)據(jù)管理員，或從事臨床研究工作； 2. 具有醫(yī)學(xué)，藥學(xué)，或相關(guān)的學(xué)歷（如護理，公共衛(wèi)生等） 3. 現(xiàn)在的工作和背景能勝任臨床數(shù)據(jù)管理員。 數(shù)據(jù)管理員的工作語言是英語，主要職能是： 1. CRF（Case report form）設(shè)計和使用數(shù)據(jù)庫及系統(tǒng) 2. Data Management Plan (DMP) 制定 3. 負責(zé)收入的臨床研究數(shù)據(jù)清理和提供報表 4. 臨床研究檔案管理 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.). 請投遞中英文簡歷，簡歷投遞郵箱：pfizerhr@sina.cn [ Last edited by liuchongyu on 2012-8-16 at 21:34 ] |
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zy120418
木蟲 (著名寫手)
- 應(yīng)助: 0 (幼兒園)
- 金幣: 1424.2
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- 帖子: 1033
- 在線: 154小時
- 蟲號: 1918257
- 注冊: 2012-07-31
- 性別: MM
- 專業(yè): 抗腫瘤藥物藥理
2樓2012-08-16 21:33:34
3樓2012-08-16 21:38:09
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4樓2012-08-21 11:38:56
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