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1年经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： Position Purpose· Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database. · Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.· Responsible for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes. · Works with the global study team to meet the study objectives.Primary Responsibilities General· Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.· Ensures Conformance to Pfizer Data Standards.· Actively participates in monthly project review meetings.· May participate in Therapeutic Area (TA) specific process improvement initiatives.Hands-on data management responsibilities (Data Manager):· Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.· Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.· Ensure timely set-up of clinical data acquisition and management tools and data validation. · Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.· Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data.· Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.· Reconcile the patient database with the Serious Adverse Event database.· Document all efforts of data management and file all responsible documents.Technical Skill Requirements· Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP· Demonstrated knowledge of data management processes and principles in area of responsibility.· Works independently, receives instruction primarily on unusual situations· Ability to organize tasks, time and priorities; ability to multi-task· Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally· Ability to work in ambiguous situations within teams to identify and articulate complex problems· Demonstrated knowledge of clinical development and regulatory submission processes and requirements. · Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology· Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.Qualifications (i.e., preferred education, experience, attributes)· Bachelor degree or equivalent in a natural/medical science, data management or related discipline. Preferred Additional Experience· Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design· Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities· Knowledge of clinical trial database and its applications · Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) 职能类别： 临床数据分析员 数据库工程师/管理员
联系方式
光谷生物城
公司信息
On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards. 辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。
