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更新于 9月22日

(Senior) Site Identification Specialist

1000-2000元·13薪
  • 上海黃浦區(qū)
  • 3-5年
  • 本科
  • 全職
  • 招1人

職位描述

藥品臨床研究Ⅰ期Ⅱ期Ⅲ期GCP證書(shū)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.

工作地點(diǎn)

上海黃浦區(qū)騰飛元?jiǎng)?chuàng)大廈

職位發(fā)布者

沙凝/人事經(jīng)理

立即溝通
公司Logo辟埃賽醫(yī)藥科技(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務(wù)的全球臨床試驗(yàn)項(xiàng)目承包商,為制藥和生物技術(shù)行業(yè)提供廣泛的臨床試驗(yàn)服務(wù),以幫助臨床藥物的開(kāi)發(fā)。PSI在歐洲、北美和南美、亞太和南非擁有2200多名員工和40多家分支機(jī)構(gòu)。
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