Sr Clinical Trial Coordinator - B&P (Budgeting, Agreement and Payments) - São Paulo, SP

Under the oversight of the line manager, this role is responsible for leading and executing all Budgeting, Agreements and Payments (B&P) activities across assigned clinical trials and sites. The Sr. Clinical Trial Coordinator (CTC) - B&P ensures the development, negotiation, maintenance and close-out of study budgets and contracts, while overseeing investigator payments, financial compliance requirements and reporting activities.

The role is critical to ensuring timely study start-up, maintenance and close-out activities through effective financial planning, contract management and stakeholder collaboration. The Sr. CTC - B&P works closely with Clinical Operations, Finance, Legal, Study Teams, Investigators and external vendors to ensure compliance with company policies, local regulations and applicable guidelines.

Responsibilities include, but are not limited to:

• Budgeting, Agreements and Payments

• Collaborate with finance/budgeting representatives, study teams and external stakeholders to:
• Develop, control, update and close-out country and site budgets, including split-site budgets
• Develop, negotiate, approve and maintain clinical trial agreements and related contracts (e.g., CTRAs)
• Track, monitor and report contract negotiation status and associated metrics
• Update and maintain contract templates in collaboration with the Legal Department
• Calculate, process and execute payments to investigators, vendors and grant recipients in accordance with applicable procedures
• Ensure adherence to financial, compliance and operational requirements throughout the study lifecycle
• o Monitor financial activities, disclosures and compliance documentation to ensure accuracy and completeness
• Maintain and update budgeting, contract and payment tracking tools and reporting systems
• Obtain, review and process FCPA documentation and related compliance records in a timely manner
• Support study teams with budget forecasting, financial tracking and issue resolution
• Identify and escalate risks, delays or compliance concerns related to budgets, contracts and payments
• Ensure all activities are conducted in accordance with ICH-GCP, company SOPs, local regulations and applicable policies

Main Requirements:

• Bachelor's Degree required;
• Fluent in Portuguese and business proficient in English (verbal and written);
• Proven experience in clinical trial budgeting, contract negotiation and payments management;
• Strong understanding of clinical trial agreements (CTRAs), financial processes and compliance requirements;
• Knowledge of FCPA requirements and associated documentation processes;
• Strong analytical and financial management skills;
• Advanced Microsoft Excel skills required;
• Good understanding of Global, Country and Regional Clinical Research Guidelines;
• Knowledge of ICH-GCP appropriate to the role;
• Excellent negotiation, stakeholder management and communication skills;
• Strong organizational skills with the ability to manage multiple priorities simultaneously;
• High sense of accountability, urgency and attention to detail;
• Ability to work effectively in a matrixed and multicultural environment;
• Demonstrated customer focus and commitment to quality;
• Ability to work independently while collaborating effectively across functional teams.

#ClinicalTrialsBR

#LI-DNI

Required Skills:

Adaptability, Adaptability, Audit Trails, Budget Development, Budget Management, Clinical IT, Clinical Research, Clinical Research Management, Clinical Study Design, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Monitoring, Compliance Monitoring, Compliance Reporting, Contract Processing, Customer-Focused, Data Analysis, Documentation Preparation, Financial Budgeting, Financial Compliance, Good Clinical Data Management Practice (GCDMP), ICH GCP Guidelines, New Technology Integration, Payment Handling {+ 8 more}

Preferred Skills:

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