375273BR
May 26, 2023
Australia
Job Description
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 a SSO (Study & Sight Operations) Contracting Specialist.
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.
Role location is flexible.
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
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.
Role location is flexible.
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
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
Minimum Requirements
• 1+ years of experience in clinical operations or equivalent
• Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
• 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?
236 million lives were touched by Novartis medicines in 2022, 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 achieve here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• 1+ years of experience in clinical operations or equivalent
• Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
• 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?
236 million lives were touched by Novartis medicines in 2022, 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 achieve here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
GCO GDD
Australia
Sydney
AU Pharma Pty Ltd
Research & Development
Full Time
Regular
No
