Job Description

About the role

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 [Role]! #GCO.

Job Purpose:

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

Role 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

Languages:

• Fluent in both written and spoken English, local language as needed

Experience/Professional requirement:

• 1+ years of experience in clinical operations or equivalent. Understanding of clinical drug development with particular emphasis on trial set-up, and contracting

Competencies:

• 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/EMA), local/National Health Authorities regulations and Novartis standards

Skills & Knowledge:

• 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

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GCO GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

Novartis