Summary
~支持在时间表、预算、质量/合规性和绩效标准范围内协调、准备和执行临床试验和/或支持活动。
About the Role
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
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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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account。
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Division
Development
Business Unit
Innovative Medicines
Location
China
Site
Beijing (Beijing)
Company / Legal Entity
CN14 (FCRS = CN014) China Novartis Institutes for BioMedical Research Co., Ltd.
Functional Area
Research & Development
Job Type
Full time
Employment Type
正式
Shift Work
No