REQ-10010721
Juni 18, 2024
China

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

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

Development
Innovative Medicines
China
Beijing (Beijing)
Research & Development
Full time
正式
No

无障碍及便利 设 施

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REQ-10010721

Contracting Specialist

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