长沙招聘

工作职责:

As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist and Trial Lead (CDS) is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio.  The CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The CDS may have direct reports.

? Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence? Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting

? Partners with Research/Business Units, external DM service providers and internal DMM staff to deliver high quality data management for all studies as assigned.

? Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).

? Ensure work carried out by or on behalf of DMM is in accordance with applicable SOPs and working practices.

? Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems. 

? Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.

? Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release. 

#LI-PFE

任职资格:

1. Public health and prevention and other related professional bachelor degree;

2. More than 5 years’ experience in clinical data management, familiar with related with the position including CRF design, database, edit check specification and data cleaning, the main process, familiar with data management and statistical analysis software;

3. Familiar with clinical study design and quality requirements.

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。