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?
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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