长沙招聘

Position Title: Database Manager, 5 Positions
Zone / Line: Clinical Data Service (CDS), China Research and Development Center (CRDC)
Location: Shanghai, China


Position Purpose
The Database Manager (DBM) is a primary technical point of contact responsible for database development, validation, and delivery in support of clinical trials data management and programming. Areas of activity include but are not limited to: Randomization, medical coding, clinical trials database setup, validation procedure programming, electronic data processing and loading, lab normal range maintenance, clinical data listing and reporting for review, data transfer, and project documentation in compliance with SOPs and regulatory requirement. DBM also provides technical support for electronic data capture (EDC) and all other database issues.

Primary Duties:
General:
? Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
? Perform activities and provide technical expertise to set up and test data collection including but not limited to EDC, case report forms (CRFs), Patient Reported Outcome (PRO), electronic data loading, PK/PD data acquisition, medical lab normal ranges, and data integration, randomization, medical coding, etc.
? Create and write programs to assist data manager to ensure study data quality
? Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
? Able to resolve conflicts, influence and communicate with key stakeholders and customers.

Functions:
? Database design: Design, create and test clinical database to ensure data collection tools and databases align with the protocol and adhere to GCP, SOPs, corporate standards and regulatory requirements.
? eData & PK/PD processing: Define the electronic data collection, develop data file specifications, create translator programs, conduct UAT testing, load eData files, and maintain documentations for electronic data & PK/PD data acquisition and reconciliation.
? Randomization generation, maintenance and release
? Medical lab: Setup lab ID and normal ranges, perform lab ID and normal ranges data entry, provide support for lab tests coding and unit conversion for lab data integration, review, and reporting.
? Database analyst/visualization: Develop and maintain programs in support of edit checks and ad hoc report programming for data cleaning and clinical data review.

Training & Education Preferred:
Bachelor's degree or equivalent experience in a scientific discipline is required.

Prior Experience Preferred
? Technical expertise and business experience in supporting clinical trials database development, data acquisition, medical lab data collection (lab tests, units, and normal ranges), etc.
? Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
? Project management skills and technical capabilities as well as effective verbal and written communication skills, with good time management skill
? Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

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。