Q1
Walk us through your experience with electronic data capture (EDC) systems. Which platforms have you used, and how do you approach data validation and query management in those systems?
Why they ask this:* They need to verify hands-on proficiency with industry-standard EDC tools (Medidata Rave, Oracle InForm, etc.) and your understanding of core CDM workflows like query resolution and audit trails.
Q2
Describe your experience with CDISC standards (SDTM, ADaM, Define-XML). How have you applied these standards in preparing datasets for regulatory submissions?
Why they ask this:* CDISC compliance is critical for FDA submissions and cross-trial data integration. This assesses whether you can structure data to meet regulatory expectations and industry best practices.
Q3
Tell us about your experience with database design and SQL. Can you give an example of a complex query you've written to identify data inconsistencies or perform reconciliation in a clinical trial?
Why they ask this:* They want to confirm you can independently query databases to troubleshoot data issues, perform audits, and support statistical analysis without constant DBA support.
Q4
How do you stay current with data management regulations and guidelines, such as 21 CFR Part 11, ICH-GCP, and protocol amendments? Give an example of how you've implemented a regulatory requirement in your work.