R&D-TMF Document Specialist-Wuhan(职位编号：966702_1339142672)
辉瑞（中国）研究开发有限公司
- 公司规模：10000人以上
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-12-21
- 工作地点：武汉
- 招聘人数：1
- 工作经验：应届毕业生
- 学历要求：本科
- 语言要求：普通话精通
英语精通 - 职位类别：文档工程师
职位描述
Responsibilities
职位描述:
Pfizer Wuhan R&D Center Job Posting - Trial Master File Document Specialist
临床试验文档专员- 工作地点武汉
The TMF Document Specialist is responsible for supporting TMF completeness through the review, coding, tracking/validation of paper and electronic documents. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any mis-indexed or incomplete documents with the Document Owner. Upon direction, the TMF Document Specialist will create and activate the TMF repository and process corresponding templates and program level documents into the repository.
临床试验文档专员（TMF Document Specialist）通过对纸质和电子文件的检查、编码、跟踪／验证以支持临床试验文档（TMF）的完整性。临床试验文档专员应及时准确地识别和处理TMF并帮助文档所有者纠正文件的错误索引。临床试验文档专员根据要求会创建并激活TMF数据库，并将相应的模板和药物项目文件导入到数据库中。
Major Responsibility
Upon direction, create and activate the initial TMF repository according to finalized study TMF specifications.
根据要求，按照完善的临床试验文档技术规范创建并激活初始TMF数据库。
Associate existing templates and program level documents to the TMF repository.
关联现有的模板和药物项目水平的文档并导入TMF数据库。
Upon receipt of paper documents, review documents to for completeness (i.e. missing pages) and ensures criticality assignments and indexing terms are accurate on all documents received.
在收到纸质文档后，审核文档的完整性（是否有页面缺失）并确保对所有接收文档的紧急程度的指派和索引词汇的准确性。
Prepare and process/upload documents including application of full indexing terms within the TMF system within specified departmental timelines, based on document criticality. Review uploaded documents for readability and verify indexing terms were transferred correctly from the document into the TMF system.
按照文档的重要性和紧急性，在部门规定的时间内，准备、处理／上传文档，包括在TMF系统中应用完整的索引词。检查已上传报告的可读性以及验证索引词是否已正确地从报告中摘引到TMF系统中。
Upon notification, archive documents as needed, per the archival process.
根据提示要求，根据归档流程对文件进行必要的存档。
Perform document completeness QC on all received documents per TMF Readiness Criteria including readability.
根据TMF质量标准对所有接收的文件进行文档完整性和可读性的QC。
Review documents for indexing accuracy; check submitted indexing terms and index document with full attributes as needed.
检查对文档索标引词的准确性进行检查，；对提交的索引词进行检查并按需要对文件的全部属性进行编引。
Follow-up with Document Owner for discrepancies and log errors.
如有不一致或错误，与报告所有者跟进加以解决。
Review TMF repository to verify an exact duplicate of the document has not previously been activated.
检查TMF数据库，确保没有完全相同的副本在之前曾被激活。
Activate document into the repository and inform Document Owner, as applicable
在数据库中激活文件并通知已知的报告所有者。
Training & Education Requirement
Minimum of Bachelor's degree or equivalent required.
本科或以上学历
Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records preferred
有在严格的法规环境中（临床研究）管理文档记录的经验，或处理临床／医学试验记录的经验的优先
Experience with the following applications types is preferred: Electronic documentation management systems / Web based data management systems / Database utilization
有电子文件管理系统/基于网络的数据管理系统/数据库应用经验的优先
Excellent English verbal and written communications skills, combined with outstanding listening skills are required.
优秀的英语听说和书面沟通能力
History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
有客户服务工作经验并有满足解客户需求和关切的良好表现。
History of achievement in building strong customer relationships.
与构建良好客户关系的经验。
Experience Requirement
Hands-on experience with electronic documentation management systems.
拥有电子文档管理系统的操作经验
Experience in management of medical/clinical study records and documentation
拥有医药、临床试验研究记录和文档的管理经验
Experience/knowledge of ICH/GCP documentation requirements
拥有ICH/GCP文挡规范的方面的经验或知识
Technical Competency Requirement
Working knowledge of electronic document management systems ; Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
电子文件管理系统的工作经验；适用于制药业或相关行业的适用的传统和电子记录管理的原则及实践和规则知识。
Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task.
能独立工作，能安排任务、时间和划分优先级；，能多任务工作。
Ability to communicate effectively and appropriately with internal & external colleagues, locally and globally
能和内外部，本地及全球的同事有效、恰当地沟通。
Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
了解临床规则科学／临床研究的基本原则，能跨不同医学多个治疗领域工作。
Understanding of technologies to support document collection and archiving, awareness of CFR 21 part 11
理解支持文件收集、归档的技术，了解掌握CFR21 part11的要求。
Ability to recognize incorrect document information and work within the team to resolve problems.
能识别不正确的文件信息，并和团队和团队成员共同解决问题。
Ability to develop and carry out plans to improve one's work.
能制订并执行改进个人工作的计划 。
Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
与与他人成功合作以确保团队效率，体现辉瑞价值观。
Ability to take on new projects and adapt to new processes and procedures
能接受新的工作任务，并适应新的流程和方法。
Respond positively and constructively to changing situations; Proactively manage change by identifying opportunities and coaching self and others through the change
积极和建设性地应对情况的变化；通过在变化中寻找机会，引导自己和他人来主动地应对改变
Assist other team members to ensure timelines are met; Work collaboratively with group members and contribute to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
协助其他团队成员按时完成任务；与团队成员合作，在本地和全球范围内促进形成良好的组内河组间工作关系，实现对临床试验团队和职能部门的责任承诺。
Ability to work independently and within a team; show respect and support for all team members.
能在团队中独立自主地工作；尊重并支持所有的团队成员。
Advocate and encourage actions that improve existing approaches and systems.
倡导、鼓励改善现行的方法和系统。
Identify and build effective relationships with customers and other stakeholders.
与客户及其他利益攸关方建立良好的关系。
职位描述:
Pfizer Wuhan R&D Center Job Posting - Trial Master File Document Specialist
临床试验文档专员- 工作地点武汉
The TMF Document Specialist is responsible for supporting TMF completeness through the review, coding, tracking/validation of paper and electronic documents. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any mis-indexed or incomplete documents with the Document Owner. Upon direction, the TMF Document Specialist will create and activate the TMF repository and process corresponding templates and program level documents into the repository.
临床试验文档专员（TMF Document Specialist）通过对纸质和电子文件的检查、编码、跟踪／验证以支持临床试验文档（TMF）的完整性。临床试验文档专员应及时准确地识别和处理TMF并帮助文档所有者纠正文件的错误索引。临床试验文档专员根据要求会创建并激活TMF数据库，并将相应的模板和药物项目文件导入到数据库中。
Major Responsibility
Upon direction, create and activate the initial TMF repository according to finalized study TMF specifications.
根据要求，按照完善的临床试验文档技术规范创建并激活初始TMF数据库。
Associate existing templates and program level documents to the TMF repository.
关联现有的模板和药物项目水平的文档并导入TMF数据库。
Upon receipt of paper documents, review documents to for completeness (i.e. missing pages) and ensures criticality assignments and indexing terms are accurate on all documents received.
在收到纸质文档后，审核文档的完整性（是否有页面缺失）并确保对所有接收文档的紧急程度的指派和索引词汇的准确性。
Prepare and process/upload documents including application of full indexing terms within the TMF system within specified departmental timelines, based on document criticality. Review uploaded documents for readability and verify indexing terms were transferred correctly from the document into the TMF system.
按照文档的重要性和紧急性，在部门规定的时间内，准备、处理／上传文档，包括在TMF系统中应用完整的索引词。检查已上传报告的可读性以及验证索引词是否已正确地从报告中摘引到TMF系统中。
Upon notification, archive documents as needed, per the archival process.
根据提示要求，根据归档流程对文件进行必要的存档。
Perform document completeness QC on all received documents per TMF Readiness Criteria including readability.
根据TMF质量标准对所有接收的文件进行文档完整性和可读性的QC。
Review documents for indexing accuracy; check submitted indexing terms and index document with full attributes as needed.
检查对文档索标引词的准确性进行检查，；对提交的索引词进行检查并按需要对文件的全部属性进行编引。
Follow-up with Document Owner for discrepancies and log errors.
如有不一致或错误，与报告所有者跟进加以解决。
Review TMF repository to verify an exact duplicate of the document has not previously been activated.
检查TMF数据库，确保没有完全相同的副本在之前曾被激活。
Activate document into the repository and inform Document Owner, as applicable
在数据库中激活文件并通知已知的报告所有者。
Training & Education Requirement
Minimum of Bachelor's degree or equivalent required.
本科或以上学历
Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records preferred
有在严格的法规环境中（临床研究）管理文档记录的经验，或处理临床／医学试验记录的经验的优先
Experience with the following applications types is preferred: Electronic documentation management systems / Web based data management systems / Database utilization
有电子文件管理系统/基于网络的数据管理系统/数据库应用经验的优先
Excellent English verbal and written communications skills, combined with outstanding listening skills are required.
优秀的英语听说和书面沟通能力
History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
有客户服务工作经验并有满足解客户需求和关切的良好表现。
History of achievement in building strong customer relationships.
与构建良好客户关系的经验。
Experience Requirement
Hands-on experience with electronic documentation management systems.
拥有电子文档管理系统的操作经验
Experience in management of medical/clinical study records and documentation
拥有医药、临床试验研究记录和文档的管理经验
Experience/knowledge of ICH/GCP documentation requirements
拥有ICH/GCP文挡规范的方面的经验或知识
Technical Competency Requirement
Working knowledge of electronic document management systems ; Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
电子文件管理系统的工作经验；适用于制药业或相关行业的适用的传统和电子记录管理的原则及实践和规则知识。
Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task.
能独立工作，能安排任务、时间和划分优先级；，能多任务工作。
Ability to communicate effectively and appropriately with internal & external colleagues, locally and globally
能和内外部，本地及全球的同事有效、恰当地沟通。
Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
了解临床规则科学／临床研究的基本原则，能跨不同医学多个治疗领域工作。
Understanding of technologies to support document collection and archiving, awareness of CFR 21 part 11
理解支持文件收集、归档的技术，了解掌握CFR21 part11的要求。
Ability to recognize incorrect document information and work within the team to resolve problems.
能识别不正确的文件信息，并和团队和团队成员共同解决问题。
Ability to develop and carry out plans to improve one's work.
能制订并执行改进个人工作的计划 。
Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
与与他人成功合作以确保团队效率，体现辉瑞价值观。
Ability to take on new projects and adapt to new processes and procedures
能接受新的工作任务，并适应新的流程和方法。
Respond positively and constructively to changing situations; Proactively manage change by identifying opportunities and coaching self and others through the change
积极和建设性地应对情况的变化；通过在变化中寻找机会，引导自己和他人来主动地应对改变
Assist other team members to ensure timelines are met; Work collaboratively with group members and contribute to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
协助其他团队成员按时完成任务；与团队成员合作，在本地和全球范围内促进形成良好的组内河组间工作关系，实现对临床试验团队和职能部门的责任承诺。
Ability to work independently and within a team; show respect and support for all team members.
能在团队中独立自主地工作；尊重并支持所有的团队成员。
Advocate and encourage actions that improve existing approaches and systems.
倡导、鼓励改善现行的方法和系统。
Identify and build effective relationships with customers and other stakeholders.
与客户及其他利益攸关方建立良好的关系。
公司介绍
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。
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。
联系方式
- Email：ChinaCPWTalent@Pfizer.com
- 公司地址：1 (邮编：200000)