长沙招聘

工作职责:

Why Patients Need YouPfizer 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 AchieveIt is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans including data preparation and validation activities, among others.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

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

How You Will Achieve ItContribute to completion of project milestones and organize own work to meet project task deadlines.

Participate in Data Monitoring and Management (DMM) activities including data review and query management.

Ensure quality database design including documentation, testing, validation, and implementation of clinical data collection tools, and/or other data collection systems.

Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.

Ensure work is carried out in accordance with applicable Standard Operating Procedures (SOPs) and working practices.

Investigate logic check flags, utilizing system information, as well as applicable study documentation.

Liaise with Study Team Point of Contact, Document Owners, Trial master file (TMF) Study Owners and/or other end users to resolve document related discrepancies and issues.

Identify and investigate any potential discrepancies and review findings with the study team Point of Contact to verify.

Contribute to process improvement and additional project that may arise.

The Central Monitor is responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Central Monitor ensures risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Central Monitor works with the global study team to meet the study objectives.

任职资格:

Qualifications

Must-HaveBachelor

s Degree

Demonstrated experience or knowledge of ICH/GCP (International Council for Harmonization/ Good Clinical Practice) documentation requirements

Hands-on experience with electronic documentation management systems and/or web based data management systems

Awareness of clinical development process including knowledge and understanding of the principles of Good Clinical Practice

Understanding of regulatory requirements and relevant data standards

Consistent, detail-oriented, and dedicated to excellence

Strong oral and written English communications skills

Proficiency in the use of Microsoft Office Suite of tools

Nice-to-HaveExperience in management of medical and clinical study records and documentation

#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。