Key Responsibilities:

Accountable for coordination, preparation, and execution of clinical study contracts (Principal Investigator, Site (Health Care Organization), Institution (Health Care Organization), MSA, local vendors, etc., as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with Study Start-Up Managers, Clinical Project Managers and Finance Specialists in compliance with Novartis processes, GCP/ICH and regulatory requirements.

Accountable for budget planning, analytics and payment execution in a direct country or extended country group (OPC and satellite countries) in close collaboration with the Study Start-Up Managers, Project Managers and Contracting Specialists in compliance with Novartis processes, GCP/ICH and regulatory requirements.

Supports country SSU strategy in close collaboration with the Study StartUp Team Lead and the 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 (Principal Investigators, site (Health Care Organizations), institution (Health Care Organizations), MSA, local vendors, etc., as applicable) for assigned projects.

Tracks and oversees contract status including the dispatch and return of contracts and ensure execution and filing of same, once executed.

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.

Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.

Implements innovative and efficient processes which are aligned with Novartis strategy.

Supports country SSU strategy in close collaboration with Study Start-Up Team Lead and 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 Study Start-Up Manager, Clinical Project Manager and 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 strategies.

Cultivates productive working relationships with key opinion leaders in the field to enhance scientific credibility and promote trial awareness among stakeholders.

Supported the successful completion of all study milestones by proactively identifying potential challenges and implementing well-coordinated action plans to address them.

Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.