广州 [切换城市] 广州招聘广州生物/制药/医疗器械招聘广州临床协调员招聘

Clinical Study Manager - OTC/Consumer Health

拜耳

  • 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:2019-08-03
  • 工作地点:上海
  • 招聘人数:若干人
  • 工作经验:无工作经验
  • 学历要求:招若干人
  • 语言要求:不限
  • 职位类别:临床协调员

职位描述


1. Operational expert for the preparation, set-up and conduct of efficacy, safety, claims and consumer research testing (which includes organoleptic testing, consumer insight tests, scan and consumer panels in which a subject is physically exposed to a BCH product or active product ingredient) from involvement in development of study protocol to final study report. As such, the Clinical Study Manager contributes to the Study Concept development with regard to its operational aspects.
2. Third party and study site identification, qualification and contracting. This includes the responsibility and accountability to ensure that all applicable guidance including are followed in all aspects of the studies. However not limited to ICH Guidelines, GCP and SOPs
3. Oversees and manages the process of, and partners with CROs on the conduct of studies which also includes development and processing of all relevant study documentation including Subject Information and Consent Forms, Case Report Form (CRF), subject reported outcome questionnaires, Monitoring as well as Data Management Plans, Audit Checks, and Statistical Analysis Plans.
4. Oversees administrative activities, maintenance of study documentation including preparation and collection of competent authority and IRB/EC review and approvals.
5. Perform study initiation, interim monitoring visits with the timely completion of reports. Closing down or oversee closing down of study sites on completion of the trial including archiving study documentation and correspondence This includes as needed oversight of activities conducted by internal and external CRAs and/or CROs as they are involved in study conduct.
6. Ensure timely availability of study supplies, subject recruitment and smooth conduct of subsequent operations, including data flow.
7. Account for and reconcile all used and unused trial supplies.
8. Supports the preparation of study budgets and timelines, and oversees and manages the same, which includes processing of invoices from external vendors in YOurDocs and tracking of these against the approved study budgets.

职位要求:
? Education: Bachelor's or related degree in Life Sciences, Health Sciences or related field, or a professional nursing or medical qualification.
? Experience: Minimum of 3-4 years' experience in clinical biomedical development, with 2-3 years' experience in the field of monitoring as a CRA, preferably with experience of multi-national clinical studies. Experience as clinical study project manager is preferred. Excellent written and verbal English communication skills, interpersonal and organizational skills are must. Good knowledge in in tracking clinical study costs against the budget. Knowledge of, and adherence to ICH/GCP Guidelines, and as well as appropriate guidelines for clinical monitoring are a requirement. Knowledge and cross-functional understanding of clinical trial methodology and logistics.
? Competencies: Team player with ability to work independently to accomplish objectives within timelines established by the Clinical Development Lead and /or Project Teams, and the ability to work in a matrix organization.

职能类别:临床协调员

公司介绍

拜耳是一家全球化创新型企业,在生命科学领域的健康与营养方面具有核心竞争力。拜耳致力于以创新的产品帮助解决当今人类社会所面临的一些重大挑战。随着人类预期寿命不断延长,人口不断增长,拜耳通过专注于预防、缓解和治疗疾病的研发活动来改善人们的生活质量。与此同时,拜耳通过突破性创新引领农业未来,帮助农户、消费者得到健康、安全、可负担的食物,并且生产过程对社区、对环境友好。“拜耳:科技创造美好生活”是我们的使命,我们的目标是改善人们的生活质量。

拜耳于1863年创立,迄今已有150多年的历史,公司总部位于德国勒沃库森,全球拥有超过11万名员工。2018年财富世界500强排行榜中拜耳排名193位。早在1882年拜耳公司首次进入中国市场,至今已经超过130年。随着中国成为世界上增长最快的市场之一,拜耳也逐步加大了在这里的投入。拜耳中国总部位于上海,截至2018年12月底,拥有超过9,000名员工。2018年拜耳中国的销售额达到31.27亿欧元,折合人民币超过235亿元。

拜耳在中国有三大事业部:处方药、健康消费品和作物科学,并运营着多家工厂。早在1936年拜耳就开始在上海生产阿司匹林,目前本地生产在中国的销售额中所占比重越来越大。伴随着正在进行的一些重大投资项目,拜耳致力于成为在中国发展的主要引擎。

多年以来,拜耳作为人们心目中的理想雇主屡获殊荣,2018年我们荣膺中国杰出雇主、中国典范雇主、非凡雇主101-年度多元雇主、中国大学生喜爱雇主、最受***欢迎雇主等多个奖项。同时,拜耳也是提供均等机会的雇主。我们尊重并公平对待他人,不论其宗教、国籍、民族、文化、性别或性取向,我们重视并弘扬多元文化。“敢想|勇为”(Passion to innovate | Power to change)是拜耳的雇主品牌宣言,它概括了拜耳作为雇主的全部特点:其工作文化与公司对目前和未来员工的期望以及对他们的回报。

如需了解更多信息,欢迎访问拜耳官方网站www.bayer.com.cn

联系方式

  • 公司地址:地址:span北京