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The post holder will work as part of a team of Governance staff providing comprehensive data management support to the department.
The post holder will be leading on the development of Electronic Data Capture (EDC). review, support, validation and oversight of clinical trials database management service on behalf of Moorfields Eye Hospital NHS Trust Research and Development Department.
They will develop the use of REDCap and other academic and commercial data management systems to their full potential and manage and maintain these resources for the recording of clinical trials data, ensuring that they are compliant with Good Clinical Practice, current national and international guidelines and legislation on clinical trials, by regulatory validation documentation for all applicable databases.
Lead data management for clinical trials, using expertise in REDCap, relational databases, and SQL to design, build, and validate compliant data systems and case report forms in line with GCP, MHRA, and UK data protection requirements. Provide specialist advice to researchers on data collection, management, and interpretation, supporting study design, statistical analysis, and reporting for sponsors, data monitoring committees, and research networks.
Ensure data integrity, quality assurance, and regulatory compliance by maintaining Trial Master File documentation, developing SOPs, and resolving data quality issues in collaboration with study teams. Manage secure data storage and handling in line with UK GDPR, acting as a key contact for data queries and ensuring timely, accurate responses.
Support study setup and delivery through training at Site Initiation Visits, promoting GCP and correct data entry practices. Contribute to audit and inspection readiness, and produce clear reports and data insights. Continuously improve data management processes to meet evolving research and organisational needs, ensuring accurate and efficient delivery.