长沙招聘

Responsibilities
Position Purpose(ADM02):
*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 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(ADM02):
*Reports directly to the Registry Quality Control Head
*Liaise with Study Team Point of Contact

Resources Managed (budget and FTEs) (ADM02):
*None


Major Duties (ADM02):
General
*Upon direction, run and review the Registry Quality Control reports or other logic check mechanisms per specified cycle.
*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 tools





Training & Education Preferred(ADM02):

*Minimum of Bachelor's degree or equivalent required.


Prior Experience Preferred(ADM02):
*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.

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。