James Reddy

Data Team Lead @IQVIA

London, GB

As a Clinical Data Manager and Data Team Lead, I am responsible for overseeing the end-to-end clinical data management activities for multiple clinical trials across diverse therapeutic areas including oncology, cardiology, respiratory, and hematology. My role encompasses managing study start-up, ongoing data cleaning, discrepancy management, data reconciliation, and database locking to ensure high-quality, accurate, and compliant clinical trial data.Key responsibilities include- Leading the creation, review, and implementation of Data Management Plans (DMP), Case Report Forms (CRFs) design and annotation, and edit check specifications, including User Acceptance Testing (UAT)- Managing query generation and resolution processes to ensure timely closure of data discrepancies- Coordinating reconciliation of key clinical data such as SAE, laboratory, ECG, and other study-specific data with internal and external data sources- Conducting quality control by performing peer reviews on data cleaning activities and ensuring data readiness for interim and final database locks- Collaborating closely with cross-functional teams including clinical monitors, programmers, safety officers, and statisticians to maintain cohesive data management practices and support study timelines- Managing project documentation for audit and inspection readiness, maintaining high standards in compliance with Good Clinical Practice (GCP) and company SOPs- Leading and mentoring junior data management staff while fostering a continuous improvement environment- Monitoring vendor performance, managing timelines, and handling remote teams to drive successful project delivery- Addressing and troubleshooting data-related issues using tools such as Medidata Rave, Oracle Inform, and other EDC systems- Acting as a subject matter expert in clinical data management processes and providing strategic input to enhance data quality and operational efficiency.

KAKATHIYA UNIVERSITY

Master's Degree