EG - Clinical Research Associate(J22019)社

面议

市辖区本科及以上4年及以上

发布时间：2023-09-06

职位描述

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 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 a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables.
It is your hard work and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.
Assist Clinical Research Site Assistant in site activation activities such as gathering IIP documentation where required to ensure timely site activation.
Reviews data to ensure quality and completeness, including Quality Control (QC) review of documents.
Ensure clinical trials data are submitted to data management in a timely fashion.
Support the study clinician in ensuring patient safety and eligibility.
Ensure induction and appropriate Pfizer specific trainings are undertaken.
Provide support for coordinating with sites for finalizing budget worksheets and contractual agreements.
Maintain accurate site-level information on corporate clinical trials registry.
Support study team as needed with Regulatory, Central, and Local Ethics Submissions and responses.
Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
Maintenance of Electronic Library and Records Archive etc. to ensure audit trail is complete and accurate.
Attend investigator meeting when required.

任职资格:
Qualifications
Must-Have
Bachelor
s Degree
3+ years
experience
Experience in clinical trial administration
Demonstrated success/results in prior roles including matrix organization
Demonstrated knowledge of quality and regulatory requirements across a range of different countries
Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations
Knowledge of applications used in the clinical trials
SOP compliance knowledge and expertise on all relevant SOPs
Effective verbal and written communication skills, and must be fluent in English
Proficiency in Microsoft SharePoint, SharePoint Designer etc
Nice-to-Have
Master
s degree
Relevant therapeutic area experience
High level of project management skills

其他要求

招聘人数：1人
职能类别：临床研究经理CRM

公司介绍

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。