长沙招聘

工作职责:

ROLE SUMMARY

As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management organization, the Manager, Project Manager, Clinical Database Management is responsible for the provision of project management leadership and expertise in data monitoring and management with an emphasis on clinical databases and related technologies supporting assigned segments of the Pfizer portfolio. Accountabilities include project management and leadership of the design, development, and maintenance of clinical databases and other technical deliverables within Data Monitoring and Management.  Oversees the development cycle/change control of database build to ensure the integrity of clinical data and the application of Pfizer standards supporting consistency in asset/submission data. Serves as a Subject Matter Expert for database build in the assigned Therapy Area.  The Project Manager, Clinical Database Management works closely with the Clinical Data Scientist to ensure consistent, timely and high quality application of process and delivery of DMM responsibilities. The Project Manager, Clinical Database Management will be accountable to assure process, technologies, and standards are leveraged in a consistent way across assigned projects.  May mentor junior staff members

任职资格:

Training & Education Preferred:

Bachelor

s degree in one of the disciplines related to drug development or equivalent business experience is preferred

? Previous project planning/ project management or related experience, preferably within clinical trials

? Experience in negotiation, facilitation and managing matrix team dynamics

Prior Experience Preferred

? Experience within the pharmaceutical or biotechnology industries is preferred

? Clinical development and business experience in order to have a through understanding of the processes associated with clinical and regulatory operations

? Excellent proficiency in verbal and written English

? Customer focused and solution oriented

? Excellent organizational and interpersonal skills

? Excellent presentation and communications skills

? Strong collaboration skills

? Financial and resource management experience

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。