更新于 9月22日

(Senior) Site Identification Specialist

1000-2000元·13薪
  • 上海黄浦区
  • 3-5年
  • 本科
  • 全职
  • 招1人

职位描述

药品临床研究Ⅰ期Ⅱ期Ⅲ期GCP证书FEASIBILITY
Overall Responsibilities
- Maintains and refines the internal site database in cooperation with Study Startup, Clinical Operations and Process Improvement.
- Participates in development of improvement strategies for the site identification process, implementation thereof, as well as related training activities.
Project Responsibilities
- Upon assignment to an awarded study, liaises with Project Management and Study Startup specialists as well as other functions involved to define the main study objectives and the optimal site profile.
- Creates the initial list of potential sites.
- Communicates with project teams on project/ regional level to fine-tune strategy and methodology of initial and follow-up site contacts depending on indication, regional particularities, and technologies in use.
- In cooperation with the project team maintains a study site identification tracker, or an analog thereof, for further site evaluation and selection activities.
- Liaises with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives.
- In cooperation with Legal, performs due diligence check of regulatory and legal limitations applicable to the recommended investigators or clinical sites.
- Participates in project team meetings during study startup, as needed.
- Supports the project team throughout study startup and further on, whenever additional rounds of site identification are necessary, and/or additional information on the site/investigator is needed.
Qualifications
- Bachelor's and above Degree in Medicine, Pharmacy and relevant Life Sciences major.
- Minimum 2 years of experience in site identification/ study startup
activities.
- Excellent knowledge of ICH GCP, local laws and applicable regulations in the region.
- Fluent in oral English.
- Well-developed communication and organizational skills.
- Ability to negotiate and build relationships at all levels.

工作地点

上海黄浦区腾飞元创大厦

职位发布者

沙凝/人事经理

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公司Logo辟埃赛医药科技(上海)有限公司
PSI is a leading full-service global Contract Research Organization providing a wide range of clinical trial services to the pharmaceutical and biotechnology industry, mainly for the development of clinical drugs. PSI has 2,200+ employees and 40+ affiliates in Europe, North and South America, Asia Pacific and South Africa. PSI是一家提供全方位服务的全球临床试验项目承包商,为制药和生物技术行业提供广泛的临床试验服务,以帮助临床药物的开发。PSI在欧洲、北美和南美、亚太和南非拥有2200多名员工和40多家分支机构。
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