Registry Quality Control Associate 武汉

月薪：

该公司所有职位
  • 1年经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Position Purpose:· The Registry Quality Control Associate is responsible for supporting Registry Data Quality and completeness by performing Quality Control on attributes submitted to the CTMS, utilizing data from within the system, as well as other systems (PTMF, ARGUS, EPM, iCTD) and source documents to validate the Registry Data Attributes, and will escalate any potential quality issue (missing or incorrect data). The Registry Quality Control Associate will work with the Study Team Point of Contact to resolve any verified quality issues. The Registry Quality Control Associate will work with the Registry Quality Control Head, Registry Quality Control Associate Group Lead, Registry Quality Control Group Lead and CTMS OSMs to review and authorize any system business rule overrides required to correct the Registry Data Attributes. The Registry Quality Control Associate will serve as the first point of contact for customers needing assistance with Clinical Trial Management System management questions and issues, and will serve as a subject matter expert for the Registry process, related systems and tools. Organizational Relationships：· Reports directly to the Registry Quality Control Head or Registry Quality Control Group Lead· Liaise with Study Team Point of ContactResources Managed (budget and FTEs) :NoneMajor Duties ：General：·Upon direction, run and review the Registry Quality Control reports or other logic check mechanisms throughout clinical study life. ·Investigate logic check flags, utilizing system information, as well as applicable study documentation,·Review data attributes populated by general users for adherence to Registry Data Quality Specifications,·Identify and investigate any potential discrepancies Review findings with the study team Point of Contact to verify data quality issues·Create, modify or delete data attributes in the CTMS system according to Registry Data Entry specifications.·Generate required metrics for each study·Function as subject matter expert for Registry systems and toolsTraining & Education Preferred:· Minimum of Bachelor’s degree or equivalent required. Prior Experience Preferred:· Excellent English verbal and written communications skills and outstanding listening skills are required. · History of achievement in a customer service role with demonstration of meeting customer needs and concerns required.· Proven history of leadership roles within a team environment required.· Experience with Clinical Trial Management Systems preferred.· Experience in management of medical/clinical study records and documentation preferred.· Experience/knowledge of ICH/GCP documentation requirements preferred.· Metrics management experience (preferably within the field of Clinical Research) preferred. · Experience with web based data management systems preferred. · Experience with database utilization preferred.Technical Competencies:Competency · Computer savvy with widely used systems e.g. MicroSoft Office· Understanding of a Clinical Trial Management System and its components· Organizational skills· Administrative excellence· Clinical/Scientific aptitude· Technology management· Decision Making· Problem SolvingDetail / Comments (specific skills, etc.)· 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· Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task.· Attention to detail evident in a disciplined approach to document maintenance and management· Understanding of scientific/clinical principles, and ability to work across different therapeutic areas · Understanding of technologies to support data attribute collection and data entry, awareness of CFR 21 part 11 · Ability to understand the sources of various data points, and how to mine that information for meaningful data· Ability to make routine decisions based on following set guidelines and procedures· Ability to proactively identify issues and work within a team to address. Behavioral Competencies:Competency · Leadership skills· Communication skills· Quality Awareness · Collaborative, supportive· Innovation· Networking and Alliance Building· Learning Organization· Flexibility · Teamwork· Initiating and Implementing change· Customer FocusDetail / Comments (specific skills, etc.)· Ability to successfully provide leadership within a team environment.· Advanced ability to communicate effectively and appropriately with internal & external colleagues, locally and globally· Ability to communicate new concepts, assess effectiveness of communication, and develop different approaches as necessary · Ability to develop and carry out plans for self-improvement.· Work successfully with others to ensure team effectiveness and demonstrate Pfizer values· Recommend continuous process improvements· Identify opportunities for collaboration to help deliver study goals · Understand which groups or individuals to approach for guidance on processes or systems, and build relationships with those individuals or groups. · Contribute to a learning environment by sharing knowledge and best practices within and across teams. · Demonstrate desire and ability to expand personal knowledge of Pfizer processes and systems. · Maintain a positive learning environment by encouraging questions and providing answers in a supportive way· Ability to take on new projects and adapt to new processes and procedures· Respond positively and constructively to changing situations· Assist other team members to ensure timelines are met · Ability to work independently and within a team; show respect and support for all team members.· 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· Advocate and encourage actions that improve existing approaches and systems.· Proactively manage change by identifying opportunities and coaching self and others through the change· Identify and build effective relationships with customers and other stakeholders. 职能类别： 药品生产/质量管理 临床数据分析员

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。

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