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china SSO Contracting Specialist

  • Location
    (CHINA) and Beijing
  • Job Reference
    18702
  • Functional Area/Experience
    / Fresh Graduate

Job Description & Qualifications

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as SSO Contracting Specialist! #GCO

Location: Open to Shanghai/Beijing city

Job Purpose:

The SSO Contracting Specialist is accountable for coordination, preparation, and execution of clinical study contracts (PI, site, institution, MSA, local vendors, etc. as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in compliance with Novartis processes, GCP/ICH and regulatory requirements.

Your responsibilities include, but are not limited to:

  • 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

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

  • 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.
  • 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.
  • Strong interpersonal, negotiation and conflict resolution skills
  • Independent, dynamic, structured and committed way of working
  • Communicates effectively in a local/global matrixed environment

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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 Accessibility and Accommodations Novartis is committed to working with and for people with disabilities They provide reasonable amenities. If you require a reasonable accommodation during any part of the recruitment process due to a medical condition or disability, or to perform the essential functions of the position, please email diversityandincl.china@novartis.com with your needs and contact information and contact us at Attach your job application number to the email.

Division

Global Drug Development

Functional Area

Research & Development

Job Type

Full Time

Early Talent

Yes



Job Skills/Competencies Required

  • Demonstrated ability to problem solve and mediate complex issues
  • Strong interpersonal, negotiation and conflict resolution skills
  • Independent, dynamic, structured and committed way of working
  • Communicates effectively in a local/global matrixed environment
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