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临床试验合同专员

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面议
北京朝阳区
1-3年
本科
全职
诺华(中国)生物医学研究有限公司
职位截止日期:2024-08-07
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职位福利

五险一金
节日福利
带薪年假
住房补贴
晋升机会
定期体检
弹性工作

职位描述

Contracting Specialist About the role: Supports coordination, preparation and execution of clinical trial(s) and /or supporting activities within schedule, budget, quality /compliance and performance standards. Key Responsibilities: -Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead and SSO Study Start-UpManagers to ensure SSU timelines and deliverables are met according to country commitments -Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc. as applicable) in assigned projects -Tracks and oversees contract status incl. dispatch and return of contracts -Negotiates financial & legal conditions, escalates issues as applicable​ -Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics) ​-Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs -Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements -Implements innovative and efficient processes which are in line with Novartis strategy Essential Requirements: -Commercial or medical training (e.g., vocational qualification) or a degree in scientific or health discipline with experience in clinical operations and/or project management -Fluent in both written and spoken English, local language as needed -1+ years of experience in clinical operations or equivalent -Understanding of clinical drug development with particular emphasis on trial set-up, and contracting -Demonstrated ability to problem solve and mediate complex issues -Understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards Desirable Requirements: -Strong interpersonal, negotiation and conflict resolution skills -Independent, dynamic, structured and committed way of working Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

职位要求

专业要求
药学
最低学历
本科
工作年限
1-3年
职称要求
初级

工作地址

北京朝阳区针织路23号楼国寿金融中心
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