Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
The role:
The Senior Associate Clinical Contracts & Budgets (SCBA) manages all site-related contracting and budget negotiations according to the current ICH-Good Clinical Practice guidelines, the Standard Operating Procedures (SOPs) and the applicable laws and regulations. SCBA also supports contracting with local vendors and ensures payments in accordance with contracts.
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.
