The SSO Contract 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.

Location: Novartis, Prague, Czech Republic #LI-Hybrid
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
• 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

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

You’ll receive:
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 12,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); Public Transportation allowance; Multi Sport Card, Employee Share Purchase Plan. Find out more about Novartis Business Services: https://www.novartis.cz/

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

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to <di.cz@novartis.com> and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Development

Innovative Medicines

Czech Republic

Prague

CZ02 (FCRS = CZ002) Novartis s.r.o

Research & Development

Full time

Regular

No