Clinical Data Analyst

A Clinical Data Analyst (or Clinical Informatics Analyst) is a clinical research information professional responsible for verifying the validity of clinical trials and data gathered. He/she will ensure that processes and protocols are followed, regulations and company standards are followed, and the analysis goals are achieved, with quality and efficiency.

A Clinical Data Analyst’s primary responsibility is to ensure that data is accurate and reliable throughout the clinical trial conduct, analysis, and regulatory submission. The information collected and produced is free of errors, relevant, and sound. All in all, a Clinical Data Analyst is at the center of data management for an organization, right from planning and execution to completion of a clinical study phase.

Essential Functions and Responsibilities

validating results and conclusions from clinical research

overseeing external and internal data management activities

expanding or modifying the system to serve new purposes and improve workflow

designing clinical and administrative reports

reviewing, extracting, compiling, and analyzing study data for compliance, quality, and accuracy, and undertaking quality improvement initiatives

coordinating with other relevant departments (e.g., study management team, clinical operations, clinical data management, and biostatistics) to determine the areas to be analyzed and see that appropriate measures are taken to ensure data analysis is useful

identifying necessary resources, developing plans for data-related projects, and determining timelines and milestones

performing data validation, data reconciliation, and data surveillance

conducting training for technical and software programs