临床试验文档专员TMF Document Specialist 武汉

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  • 无工作经验
  • 本科
  • 招5人
  • 11-09 发布

职位描述

职位描述： TMF Document SpecialistPosition Title:TMF Document SpecialistReports To:Lead TMF Document SpecialistZone / Line:Development Operations, WRDCLocation:WuhanPosition Purpose:The TMF Document Specialist is responsible for quality control of TMF documents in the TMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any incomplete, mis-indexed, or inaccurately scanned documents with the Document Owners/TMF Study Owners or other end users.Organizational Relationships:Report directly to the Lead TMF Document SpecialistLiaise with TMF Study Owners, Document Owners, and Document Submitters, as neededResources Managed (budget and FTEs):N/AMajor Duties:Perform quality control on all documents received per In-line QC checklist and other reference documents.Demonstrate understanding on document types, properties and indexing requirementsEnsure overall TMF quality by checking document completeness, indexing and scanning accuracyProcess documents in the TMF system(s) within specified timelines, based on document criticality/priorityCommunicate document inquiries with responsible users as neededLiaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issuesCommunicate and escalate issues to the Lead TMF Document Specialist and TMF OperationsContribute to special projects related to document management as neededEnsure that documents are transferred correctly within the TMF system per SOP and TMF related reference documentsPrepare, upload, and process documents including application/verification of document indexing within the TMF systemTraining & Education:Minimum of a Bachelor’s degree or equivalentGood English skillsBasic computer literacyPrior Experience Preferred:Strong oral and written English communications skillsHands-on experience with electronic documentation management systems and/or web based data management systems. Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical recordsExperience/knowledge of ICH/GCP documentation requirementsHistory of achievement in a customer service role with demonstration of meeting customer needs and concernsTechnical Competencies:Competency Detail / Comments (specific skills, etc.)Computer savvy with widely used systems (e.g., Microsoft Office)Working knowledge of electronic document management systemsUnderstanding of a Trial Master File and it’s componentsKnowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industryOrganization SkillsAbility to work independently; ability to manage tasks, time and priorities; ability to multi-task.Communication SkillsAbility to communicate effectively and appropriately with internal & external colleagues on a local and global scaleAdministrative ExcellenceAttention to detail evident in a disciplined approach to document maintenance and managementClinical/Scientific AptitudeUnderstanding of scientific/clinical principles across different therapeutic areasTechnology ManagementUnderstanding of technologies to support document collection and archiving; awareness of CFR 21 Part 11Decision MakingAbility to make routine decisions based on pre-set guidelines and proceduresProblem SolvingAbility to recognize incorrect document information and work within the team to resolve problemsBehavioral Competencies:Competency Detail / Comments (specific skills, etc.)Quality AwarenessAbility to develop and carry out plans to improve one’s workCollaborative, supportiveWork with others to ensure team effectiveness and demonstrate Pfizer values InnovationAbility to identify opportunities and recommend continuous process enhancementMotivation to develop self, meet and exceed expectations, and achieve performance goalsNetworking and Alliance BuildingContribute to a learning environment by sharing knowledge and best practices within and across teamsAssist with mentoring other team members in core disciplinesLearning OrganizationAbility to learn fast in an environment that demands excellence, time, and energyWillingness to take on new projects and adapt to new processes and proceduresFlexibilityAbility to deal with ambiguity and changing prioritiesAbility to work both independently and within teams; show respect and support for all team membersTeamworkDrive, enthusiasm, creativity and excellent interpersonal skillsInitiating and Implementing changeAdvocate and encourage actions that improve existing approaches and systemsCustomer FocusIdentify and build effective relationships with customers and other stakeholders 职能类别： 临床数据分析员 生物工程/生物制药 关键字： TMF Document Specialist

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。

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