Puneet Kaur

Background

About Puneet Kaur

Clinical Data Management Specialist | 8 Years of Expertise in EDC Systems I am a dedicated Clinical Data Manager with 8 years of experience in designing and managing databases using advanced Electronic Data Capture (EDC) systems. My expertise spans across the entire clinical trial lifecycle, with a strong foundation in ICH, GCP, GCDMP, and 21 CFR Part 11 compliance, ensuring ethical research practices and data integrity. I specialize in Castor EDC, including study build, data management, and validation, as well as Medidata Rave EDC and database programming with SQL. My proficiency with Azure Data Studio, Azure Data Lake, and Wasabi Cloud Systems enhances my ability to effectively manage and archive clinical trial data. With a strong focus on software validation and supplier evaluation, I ensure that electronic systems comply with regulatory standards, including HIPAA and PIPEDA. I have authored comprehensive work instructions covering clinical data management, data archival processes, and Trial Master File document management using Florence. My hands-on experience in patient enrollment, screening, consent processes, and study monitoring equips me with a holistic understanding of clinical trial operations. A dynamic and motivated professional, I excel at managing multiple tasks simultaneously and thrive with minimal supervision. I am passionate about leveraging my expertise to contribute to successful clinical trial outcomes and improve data management processes.