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 (GBDM) organization, the Database Analyst II is responsible for the programming of high-quality clinical database and for the provision of expertise in clinical database technology. Responsible for supporting assigned segments of the Pfizer portfolio. Accountabilities to include the design, development, and maintenance of clinical databases, ensuring the integrity of clinical data, application of standards supporting consistency in asset/submission data. The Clinical Database Analyst II learns how to mentor junior staff in database technologies and Pfizer standard database conventions.  May serve as a subject matter expert on the design of ECRFs and clinical databases in one therapy area.

ROLE RESPONSIBILITIES

Works closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans

Complies with applicable SOPs and work practices

Develops expertise in one or more technologies

Develops knowledge of data capture tools and methods that support the accuracy and integrity of study data

任职资格:

BASIC QUALIFICATIONS

Bachelor

s degree in a Life Science, Computer Science or equivalent

Minimum of 2 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions

Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills

Technical skills and experience using relational databases (e.g. Oracle InForm, Oracle DMW, MS SQL Server or MS Access)

Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills

PREFERRED QUALIFICATIONS

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)

Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable

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。