长沙招聘

Zone / Line: WRDC/CRDC

Position Purpose
Pfizer’s Corporate Clinical Trial Registry (referred to as the Registry) is the definitive reference catalog of Pfizer sponsored studies, study associated regulatory events, and study sites.
The Registry Quality Control Group Lead manages staff responsible for critical functions related to ensuring the integrity of the Registry. Functions include management of Quality Control and data entry workload and the monitoring of metrics and policies/procedures for all Registry data attributes. This includes running Quality Control reports; review of potential data quality issues; entry, modification or deletion of data attributes; quality metrics collection; day to day operations and management of associated staff. The Registry Quality Control Group Lead will also create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, clarity of workload balance, and alignment within and across functional lines.
Organizational Relationships
• Reports directly to the Head of Wuhan Research and Development Center, or the TMF Processing Center Manager, or the Information Analyst Manager
• Dotted line reporting relationship to the Registry Business Process Owner
• Liaises with the Registry Quality Control Lead
Primary Duties
• Supervise the departmental staff in the daily management of Quality Control Reports. Organize and prioritize daily workload for review of the reports and discussion with study teams on needed corrections, as well as data entry into the Clinical Trial Management System (CTMS) as needed.
• Ensure adequate training of staff on Registry/CTMS procedures and policies related to Registry Data Quality guidelines and quality metrics
• Evaluate and implement strategies to ensure consistent processes and procedures for the CTMS application in collaboration with CTMS Council Chair and the Registry Business Process Owner
• Implement organizational design and develop succession planning for group
• Develop people, including recruitment, retention, and career development and performance management
• Review metric dashboards, trending reports and quality sampling reports to understand the overall health of the Registry and identify issues and opportunities for re-training
Training & Education Preferred
In general, candidates for this job would have the following levels of experience:
• Bachelor's degree or equivalent experience in a scientific/business discipline such as Medical, Pharmacology, Clinical, Life Science, Computer Science or English majors required
• Project management, resource management, administrative, and technical capabilities are required, as well as a strong background in managing and leading people. Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Experience with the following applications types is preferred:
• Clinical Trial Management Systems
• Web based data management systems, as required
• Database utilization
• Excellent English verbal and written communications skills, combined with outstanding listening skills are required
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns
• History of achievement in building strong customer relationships
• Experience supporting regulatory submissions and inspections preferred
• Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in a high stress situation is very important
• Strong background in provision of high levels of customer service evidenced by positive feedback from customers
• A sound knowledge of working across international boundaries and cultures.
Prior Experience Preferred
• Experience with web based data management systems preferred
• Experience with medical/clinical study records and documentation
• Experience/knowledge of ICH/GCP requirements
• Previous experience leading/managing a group responsible for Clinical Trial Management Systems and/or clinical study management function, or equivalent

简历收集邮箱：job-c2.china@pfizer.com.

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。