长沙招聘

工作职责:

The Senior Study Manager acts as the single point of contact for all responsible studies. The Senior Study Manager has accountability for the study end to end delivery throughout study design, start-up, conduct, analysis& reporting, study close-out, inspection readiness, submission and regulatory defense for one or more single/multiple countries studies.The Senior Study Manager is accountable for developing the operational strategy and managing the timelines, budgets, and quality across more complex studies, such as Asian studies, Global studies and studies that do not follow a currently defined model within DC.The Senior Study Manager is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category (ies).And Senior Study Manager lead and manage the core cross functional stakeholder for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.The Senior Study Manager is responsible for the line management of junior study manager, Clinical Research Associate (CRAs) to ensure quality, oversight and efficient execution of Pfizer clinical trials within the country/region in accordance with Pfizer standards, applicable laws and business needs.The Senior Study Manager is responsible for monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc.) and take appropriate targeted action. Conducts risk assessments to identify actions for mitigation and control across studies. And conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.

  

任职资格:

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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。