苏州招聘

工作职责:

Why Patients Need You 

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients. 

What You Will Achieve 

You will be part of Pfizer

s medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope. 

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. 

It is your problem solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. 

How You Will Achieve It 

Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division. 

Oversee the overall execution of clinical studies and be accountable for the development of realistic detailed study startup and monitoring plans. 

Oversee and support study start up activities at the country level, including review of key documents and providing support to address regulatory and/or ethics committee questions. Forecast and manage the Clinical Trial Budget. 

Manage full studies for Operational Study Management or manage a unique part of a larger study. 

Serve as primary point of contact for study decisions related to the protocol, data collection and volunteer activities. 

Approve and oversee drug supply management and manage flow of drug supply to the sites. 

Partner with key team members to manage the program to achieve key milestones within time, cost and quality parameters. 

Work with functional lines and directly with Contract Research Organization (CRO) line functions to resolve or triage site level issues. 

Share and escalate plan deviations to Clinical Project Manager and study team. 

Help to address Significant Quality Events or other quality issues at patient and/or site level. 

Lead the data integrity and data quality activities for assigned protocols. 

Provide regional and cross-regional insights on study-site performance and trends to / from the study team. 

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任职资格:

Qualifications 

Must-Have 

Bachelor

s Degree 

5+ years’ experience 

Demonstrated project management / leadership experience 

?Experience working in the research and development of pharmaceutical industry 

Experience conducting, managing or participating in regulatory inspection processes 

Knowledge of project management discipline and its application to vaccine development 

Country level cultural awareness and strong interpersonal skills 

Excellent communication skills, both written and verbal in English 

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Nice-to-Have 

Master

s degree 

Experience in early drug development 

Knowledge of the project management discipline and its application to vaccine/drug development 

#LI-PFE

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。