General Responsibilities/Tasks:
- Deeply acknowledges and strictly follows Excelya and Client’s SOPs, guidelines and appropriate local and international legislation.
- Negotiate contract, study budget and milestones with sites within defined parameters for clinical trials and observational studies.
- Prepare the contract with sponsors for clinical research.
- Support resolution of contract issues.
- Support contracting with local vendors.
- Maintain contract tracking in appropriate systems.
- Store and archives contracts and budgets in the appropriate systems.
- Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness.
- Work with Study Manager on the review of the budget template for country feedback on Fair Market Value and the schedule A template.
- Negotiate site budgets from the base budget and payment milestones using appropriate guidelines, and completes the final template for addition to the contract showing the final agreed budget per site.
- Is responsible for the Clinical Trials Insurance process.
- Escalate contract and budget issues to other departments as appropriate.
- Participates in appropriate meetings as required to resolve contract issues.
- Ensure payments are made in accordance with contracts and perform ongoing and / or end of study budget reconciliation with the Study Manager, as needed.
- Maintain payment data tracking in appropriate systems.
- Process and track CDAs.
- May undertake other tasks as they may be assigned from the Supervisor that will concern Excelya.
