JULY ANDREA PIRA ROMERO

Site Management Associate II on behalf of Bayer

ICON Strategic Solutions

Sep 2025 - Mar 2026 (7 months)

Serve as the primary liaison and Systematic Quality Contact for assigned clinical sites and investigators, driving strong communication and swift issue resolution.

Manage all remote site management activities for multiple clinical sites, ensuring strict adherence to the study protocol, amendments, and applicable SOPs.

Proactively manage protocols and deviations, assuring the accuracy of reported data and maintaining project timelines in alignment with the Clinical Management Plan.

Assess and review site performance on an ongoing basis, utilizing tracking systems (CTMS or others) to monitor key metrics and escalate risks to the Project Management team as needed.

Ensure 100% data integrity and regul

Sr. Clinical trials assistant on behalf of Summit Therapeutics MX, Extend Biosciences Inc ARG

ReSolution Latin America

Mar 2024 - Jan 2025 (11 months)

Managed and maintained the entire organizational structure of clinical documentation within the eTMF (electronic Trial Master File) for multi-sponsor clinical studies, ensuring quality control and audit readiness.

Oversaw financial transactions including tracking, recording, and processing payments for Ethics Committees, regulatory fees, and patient visit reimbursements; generated detailed reports for accurate financial oversight.

Provided advanced support to CRAs and the RSU (Regulatory and Site Start-Up) team by acting as the primary point of contact for sites in the collection and tracking of essential regulatory documents.

Facilitated timely regulatory submissions to national Health Authorities (Invima,

In-house CRA / Clinical trials assistant on behalf of Bayer

ICON Strategic Solutions

Jan 2023 - Apr 2024 (1 year 4 months)

Financial Management & Compliance: Managed end-to-end financial operations for clinical sites, including patient visit liquidations based on CRF data, budget parameters, and site contracts.

Systemic Financial Oversight: Created Purchase Orders (PO) in SAP, processed corresponding invoices, and ensured timely investigator payments, guaranteeing accurate financial control and regulatory compliance.

Budgetary Management: Oversaw all study-related financial transactions, including payments to Ethics Committees, patient reimbursements, and regulatory fees, with a focus on reconciliation and audit-readiness.

Contract and CTM Management: Maintained site contract records within sponsor CTM systems, managing budget m

Accounting and Financial Assistant

Strategic Solutions Division of PRA Health Sciences

Dec 2014 - Jun 2022 (7 years 7 months)

Treasury & Financial Management: Led treasury operations, managing and approving time-sensitive payments according to project contracts, and overseeing cash flow (inflows/outflows) for efficient Accounts Receivable and Accounts Payable administration.

Financial Reporting & Compliance: Prepared detailed budgets, balance sheets, and liquidations, ensuring financial accuracy and compliance with payment obligations to employees and vendors.

Cash Flow and Risk Oversight: Planned and supervised cash flow, managed investments, debt, and financial risks, continuously optimizing resource allocation to ensure the financial success of clinical projects.

Clinical Study Payments: Processed investigator payments and manag

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Accounting Assistant

Meltacajas gyj sas

Apr 2013 - Dec 2014 (1 year 9 months)

Financial Data Analysis: Utilized historical and current company budgetary information to assess confidential revenues and expenses, ensuring up-to-date financial data gathering and reporting.

System and Reporting: Leveraged World Office for accurate data entry and the preparation of core financial statements and reports.

Record Keeping & Compliance: Maintained organized and precise financial records by ensuring the correct coding and classification of all invoices.

Ledger and Journal Management: Managed accurate entries in general ledgers and financial journals to support the timely production of final financial reports.

Tax Compliance: Maintained current knowledge of national and district tax re

JULY ANDREA PIRA ROMERO

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JULY ANDREA PIRA ROMERO

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