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 Asset Lead is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio.  Responsibilities include delivery of 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 Asset Lead is expected to manage large or several smaller assets and may directly or indirectly design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Asset Lead may have direct reports. 

 

 

ROLE RESPONSIBILITIES  

As needed, serve as Clinical Data Scientist 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 

Act as the key scientific and technical data management expert; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as RBM standards, tools, data provisioning, and reporting  

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

Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.   

Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics. 

Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals, and clinical research collaborations as required. 

 Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer. 

  

任职资格:

QUALIFICATIONS  

Bachelor’s degree required.  Degree in scientific field preferred.  Master’s degree preferred. 

Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting 

Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review 

Strong Project and Risk Management 

Minimum 10 years Data Management experience required including 5+ years  team leadership  

Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements  

Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / InForm preferred)  

Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spot fire, review) 

Familiarity with Med DRA/WHO-Drug coding  

Knowledge of risk-based monitoring principles and associated analytics/metrics 

Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables 

Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment 

 

 

PHYSICAL/MENTAL REQUIREMENTS 

Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.? 

#LI-PFI

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。