职位详情
绩效奖金
带薪年假
餐费补贴
通讯津贴
定期体检
管理规范
五险一金
交通补助
Summary of Key Responsibilities:
? Acts as the main contact between the sponsor and the investigational site.
? Ensure the protection to subject safety and welfare throughout the clinical trial.
? Verifies that source data/documentation and other trial related records are accurate, complete, and integrated.
Major Responsibilities:
1. Acts as the main contact between the sponsor and the investigational site for:
1) Selection and assessment of investigational sites and investigators.
2) Obtaining EC approval for responsible investigational sites in time.
3) Management of responsible investigational sites to ensure the quality and compliance to GCP, JW therapeutics SOPs, protocol, and applicable regulations/laws.
4) Achieving site milestones on time to ensure the completion of study milestones.
5) Investigational site closure as planned.
2. Ensure the protection to subject safety and welfare throughout the clinical trial.
3. Verifies that source data/documentation and other trial related records are accurate, complete, and integrated.
4. Ensure all AE/SAEs been reported and recorded within required timeline to fulfill local regulation requirement.
5. Ensure APH and infusion process are strictly followed at sites.
6. Manages the progress of assigned sites by tracking submissions and approvals, recruitment and enrollment, case report form(CRF) completion and submission, and data query generation and resolution.
7. Collects, maintains and archives Trial Master File as requested in time.
8. Ensure inspection readiness for the responsible investigational sites.
9. Supports study manager to complete assigned tasks when requested.
Qualification:
Job Required Competencies
? Basic knowledge in ICH-GCP and China GCP.
? Clear and accurate communication with internal and external customers.
? Ability to work independently.
? Problem solving capability.
? Can work under pressure.
? Teamwork spirit.
? Effective time and financial management skills.
? Good written and read English.
Education / Qualifications
? Bachelor degree in the scientific or health related field.
? Typically requires 0-2 years’ prior relevant experience.
? Flexibility to travel when requested.
公司介绍
药明巨诺(港交所代码:2126)是一家独立的、专注于开发、生产及商业化细胞免疫治疗产品的创新型生物科技公司。创建于2016年,药明巨诺致力于以创新为先导,成为细胞免疫治疗引领者。药明巨诺已打造了细胞免疫疗法的技术与产品开发平台,以及涵盖血液及实体肿瘤、极具潜力的产品管线,以期为中国乃至全球患者带来治愈的希望,并促进中国细胞免疫治疗产业的健康规范发展。
JW Therapeutics (HKEx: 2126) is an independent, innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Founded in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring the hope of a cure for Chinese and global patients, and to lead the healthy and standardized development of China’s cell immunotherapy industry.
工商信息
以下信息来自
注册地址
中国(上海)自由贸易试验区中科路699号1幢B栋5层01室(一照多址企业)
统一社会信用代码
91310000MA1K381YXM