Site Contract

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**Site Contract & Budget Specialist / PH / São José dos Campos - SP**

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**GET TO KNOW OUR AREA**:
The main purpose of the Site Contract and Budget Specialist is to efficiently manage the generation of Clinical Trial Agreements (CTAs), refine local budgets in collaboration with the Country Lead Monitor (CLM), and effectively negotiate and manage all aspects of site clinical trial contracts and budgets. This role also involves troubleshooting associated problems to prevent delays in the execution of these agreements within the highly regulated environment of clinical research in addition other assigned countries where support is required.

**YOUR MISSION WILL BE TO**:

- Co-create with customer to set up the most effective Master Service Agreements for clinical trials to make the start of studies more efficient. Being the expert in Brazil. regarding requirement for negotiation in contracts and budget in clinical trials
- Collaborate with local Clinical Customer engagement & Operations Team to ensure smooth operational delivery of contracts and budgets with clinical investigators and scientific consulting services in order to allow for efficient and effective conduct of clinical trials.
- Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Execute CTAs in a timely manner in order to meet expected timelines for study start-up. Liaise with the legal departments of both Bayer and contract parties so that any content changes to the CTAs are mutually agreeable, and in accordance with Bayer’s legally approved standard agreement language. Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution.
- Customize country & site budgets to sites and follow up with site/site personnel as applicable. Research medical procedure costs using local or global database in order to provide accurate data for development of the site level budgets
- Negotiate budgets and Clinical Trial Agreements (CTAs) with the site/site personnel as applicable and follow up until signature
- Manage CTAs and see that all changes to agreements and corresponding components are updated according to Bayer legal standards and Bayer Global SOPs. Responsible for annual review of all clinical trial related templates with the Legal department and Local Clinical customer engagement & Operations Team as applicable
- Manage the contract tracking database, including coordination of timely updates with respect to CTA. Verify accuracy of information and reconcile discrepancies between documents and the database. Responsible for posting of fully executed contracts in eFiLiA and/or other database
- Process for each study, internal approval forms and other documents which are required for compliance with the Internal Signatory Process and are also required for annual audits.
- Maintain excellent communication and collaboration as point person in key working relationships detailed above.
- Responsible for preparing for internal audits by maintaining a complete and accurate trail for e