I have extensive experience with various clinical data management systems, including EDC (Electronic Data Capture) platforms like Medidata Rave and Oracle Clinical. I am proficient in setting up databases, managing data entry, and ensuring data integrity through regular validation checks. My experience also includes working with CRFs (Case Report Forms) and managing data queries to ensure accurate and timely data collection.

I ensure data accuracy and integrity by implementing rigorous validation processes, including double-checking data entries, conducting regular audits, and using automated checks within the EDC system. I also maintain clear documentation of all data management procedures and collaborate closely with the clinical team to resolve any discrepancies promptly.

I am well-versed in regulatory requirements such as FDA and ICH guidelines for clinical data management. I have experience in preparing and submitting data for regulatory audits, ensuring compliance with Good Clinical Practice (GCP) standards. My role often involves coordinating with regulatory affairs teams to ensure all data submissions meet the necessary standards.

I handle data queries and discrepancies by first thoroughly reviewing the data in question to understand the root cause. I then communicate with the relevant site personnel or study team members to resolve the issue. I document all steps taken to resolve the query and ensure that the corrected data is re-entered and validated to maintain data integrity.

In a previous role, I managed a clinical trial with a high volume of data and complex data entry requirements. The challenge was to ensure timely data entry while maintaining accuracy. I overcame this by implementing a streamlined data entry process, training the team on best practices, and using advanced data validation tools. This approach not only improved data quality but also reduced the time spent on data cleaning.