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 AchieveYou will facilitate in conducting clinical trials and monitoring their progress. You will coordinate all activities that support the clinical trials and assist the managers in conducting them. As an associate, your focus on the job will contribute in achieving project tasks and goals.

It is your hard work and focus that will help in making 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.

Maintain Pfizer Trial Master File (PTMF) in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs).

Review shared space to ensure others are updating tracking and files as requested by the team.

Update the trial and site information as necessary in Corporate Clinical Trial Registry in a timely manner.

Support and coordinate the Clinical Trial Application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.

Provide protocol and Informed Consent Document (ICD) Administrative Support to global Project Managers and Study Managers.

Support and coordinate any activities as requested by PMs/SMs and as assigned within required timelines.

Maintain / develop local tracking spreadsheets for study-related documents, data, activities and prepare site supportive material.

Attend appropriate training programs and project teleconferences as applicable.

Assist team with the preparation of any documents or tracking and updating information.

Identify and implement process improvements for inspection readiness, Pfizer Trial Master File (PTMF) compliance, Investigator Meeting organization.

Ensure the reconciliation of Trial Master File and the Site Master File on a periodic basis.

任职资格:

QualificationsMust-HaveBachelor

s Degree

Relevant work experience in a health related discipline, pharmaceutical or medical research

Demonstrated ability to introduce new ideas

Knowledge on all relevant Standard Operating Procedures

Ability to prioritize multiple tasks and develop strategies for completion of all required activities

Ability to build collaborative working relationships with colleagues and associates both within and external to the organization

Nice-to-HaveExperience in management of clinical trial and/or regulatory documents

Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations

Knowledge of application used in the clinical trials

  

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。