Address 393037BR
SSO Contracting Specialist
Australia
About the role
Internal Role Title: SSO Contracting Specialist
Location: Sydney, Australia #LI-Hybrid
About the Role:
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
Key Responsibilities :-
Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead and SSO Study Start-Up Managers to ensure SSU timelines and results 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 is responsible for contract status incl. dispatch and return of contracts.
Negotiates financial & legal conditions, brings up 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.
Role Requirements
Essential Requirements:-
Commercial or medical training (e.g., vocational qualification) or a degree in scientific or health field with experience in clinical operations and/or project management
1+ years of experience in clinical operations or equivalent
Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
Proven ability to problem tackle and mediate sophisticated issues
Understanding of the international aspects of drug development process, including solid understanding 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?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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
Division
Development
Business Unit
GCO GDD
Work Location
Sydney
Company/Legal Entity
AU Pharma Pty Ltd
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
