上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海临床研究员招聘

Clinical Research Physician, Dermatology disease

葛兰素史克(中国)研发中心

  • 公司规模:150-500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:2013-01-09
  • 工作地点:上海
  • 招聘人数:若干
  • 工作经验:三年以上
  • 学历要求:硕士
  • 语言要求:英语熟练
  • 职位类别:临床研究员  

职位描述

Job Purpose and Key Responsibilities:

Provide medical expertise to clinical trials and new product registration in dermatology area in China


Accountability:

1. Clinical trial activities:

1.1 Ensure all clinical studies operate to the highest level of ethical and safety standards and in compliance with GCP, SOPs and regulatory requirements

1.2 Develop appropriate protocol synopsis and protocols to support research proposals and meet local
registration need

1.3 Actively participate feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback.

1.4 Translate final protocols and amendments for global/regional studies

1.5 Assist with study operation team in Coordinating Principal Investigator and leading site selection

1.6 Develop local ICDs (Informed Consent Document), and translate as needed

1.7 Prepare and deliver presentations for product and protocol introduction at investigator meetings and trainings to study team

1.8 Act as protocol and clinical lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators

1.9 Provide valuable inputs in SAP (statistical analysis plan) finalization and efforts in achieving Database clean

1.10 Prepare and finalize local clinical study report, and assist NDA submission

2. Maintain high level of clinical understanding of GSK products and assigned disease area, provide knowledge training to study team as needed

3. Establish and Maintain an effective network of relationships with key opinion leaders in assigned disease area


Complexity:

1. Need to actively monitor and respond to internal and external changes and uncertainty and ensure subject safety and data integrity well protected

2. Need to influence internal or external stakeholders

3. Give input to Therapy Matrix Team and able to lead a project teal for planning and delivery


Basic Requirements:

Minimum master degree in clinical medicine

At least three year practice in hospital with specialty in dermatology or relevant area or in clinical/medical team

Good command of English (written and spoken)

Knowledge of PC (WORD, EXCEL, POWERPOINT)

Interpersonal communication skill

Team player

Presentation skill

Influential skill


Preferred Requirements:

Knowledge of clinical development and regulatory requirements

Project Management

公司介绍

葛兰素史克是最早在中国大规模投资研发领域的国际制药公司之一,通过与中国政府、学术机构和医疗专家保持密切的合作,致力于提高中国人民的健康水平。在进入中国的20多年间,我们在国内的药物研发和临床研究方面已投入了10亿元人民币。我们的目标是使中国成为葛兰素史克全球研发体系中一个重要的战略中心。

联系方式

  • 公司网站:http://www.gsk.com
  • 公司地址:上海市张江高科技园区哈雷路898弄3号
  • 邮政编码:201203
  • 联系人:HR