Summary
About the Role
Location: you can be based anywhere in Hungary but there is a need to come to the office once per week
Major accountabilities:
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 deliverables are met according to country commitments
Responsible for accounting and execution of investigator payments in a direct country or extended study group (OPC and satellite countries) in close collaboration with SSO Study Start-Up Manager, SSO Clinical Project Manager and SSO Contracting Specialist in assigned projects
- Project controlling & budget management supports financial planning, forecasting and management, analyses and reports project costs and their drivers
- Set up & validation of investigator contracts in the accounting system for clinical studies
- Executes and monitors internal controls
- Translates Grant Plans into local Payment Schemes
- Prepares and submits country TCF(s)
- Updates systems (ACT, Optimus, etc.)
- Executes payments, communicates with sites when it comes to payment issues
- Tracks and oversees payment status
- 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
- 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
Key performance indicators:
- 1. Performance against budget planning and payment commitments at the country level, especially set-up/delivery of trials per defined contracting timelines and milestones (coordination, preparation, and execution of clinical study contracts and amendments)
- 2. Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- 3. Timely submission and delivery of high-quality clinical trial documentation/data
Minimum Requirements:
Education:
- Commercial or financial training (e.g., vocational qualification) or a degree in scientific, finance or economics discipline with experience in clinical operations and/or project management
Work Experience:
- Cross Cultural Experience.
- Collaborating across boundaries.
- 1+ years of experience in clinical operations or equivalent
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
Skills:
- Strong financial and business economics background
- Strong process and system understanding
- Independent, dynamic, structured and committed way of working
- Communicates effectively in a local/global matrixed environment
- Strong interpersonal, negotiation and conflict resolution skills
Languages :
- Fluent in both English and Hungarian
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 reac h our ambitions. Be a part of this
mission and join us! Learn more here: https://www.novartis.com/about/strategy/people and culture
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish tostay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/networkhttps://talentnetwork.novartis.com/network
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
