(高级)临床试验监察专员(J20101)
辉瑞制药有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-06-04
- 工作地点:北京-东城区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:1.5-2万/月
- 职位类别:临床监查员
职位描述
工作职责:
Job De"script"ion
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
职能类别:临床监查员
公司介绍
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元,研发投入78亿美元。辉瑞在全球拥有9万多名员工,59家生产基地,业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域,同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。每天,分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个,其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗,辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓,并以其优异的品质深受广大消费者的青睐;辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
联系方式
- Email:chinahrwest@Pfizer.com
- 公司地址:南京西路中信泰富