Clinical Data Associate
Current• Assisted in Developing Safety Data Review Plans: Assisted in the creation and updating of safety data review plans, focusing on laboratory data, adverse events (AEs), serious adverse events (SAEs), and key safety metrics. My contributions ensured these plans were thorough and aligned with study protocols.• Performed Safety Data Reviews: Conducted safety data reviews, identifying potential issues in AEs, SAEs, and other critical medical events. Escalated findings to senior team members for resolution, ensuring participant safety was maintained throughout the trial.• Performed Safety Data Reviews: Worked closely with Clinical Data Managers and Project Managers to maintain data accuracy and quality. Documented discrepancies and ensured timely resolution, supporting the integrity of the clinical trial data.• Assisted with Medical Coding: Provided support in coding AEs, medical histories, and medications using MedDRA and WHO Drug dictionaries. This ensured consistent and accurate data collection and analysis across the clinical trial.• Supported CRF Review and Protocol Processes: Assisted in reviewing Case Report Forms (CRFs) and trial protocols, contributing to accurate and consistent data collection processes, particularly in laboratory data.• Maintained Laboratory Data Accuracy: Coordinated with Clinical Data Managers to verify laboratory data accuracy, ensuring it aligned with review checklists and protocols, thus supporting high standards of data integrity.• Participated in Data Management Projects: Contributed to Clinical Data Management projects, focusing on data verification and compliance with established standards, ensuring efficient data management processes in line with regulatory requirements.
