Laura

Extract and organize data from various sources, including databases, spreadsheets, and external datasets, ensuring data quality by identifying and addressing errors to maintain data integrity. Support data normalization, as well as database development, maintenance, and reorganization, to streamline data management processes. Additionally, create reports and dashboards that communicate analysis results, highlighting data trends, patterns, and predictions to provide insights based on relevant data, supporting decision making.

Ensure the accurate and timely collection, validation, and quality assurance of oncology clinical trial data, working in compliance with ICH-GCP guidelines and regulatory standards. Conducting data integrity reviews, reconciliation, query management, and supporting medical coding and database lock preparation. Oversee data from multiple sources, including case report forms (CRFs), lab results, and patient records, collaborating with clinical operations, regulatory affairs, (CRAs), and site staff to resolve data issues and support trial design and execution. Additionally, prepare data for regulatory submission and contribute to the development of clinical study reports.