- Review study protocols and design CRFs and data validations to meet study aims.
- Coordinate CRF development and study set-up with study committees and teams.
- Construct CDISC/CDASH variables and fragments adhering to SOPs.
- Perform User Acceptance Testing within the study EDC.
- Create and maintain an integrated study data management plan (DMP).
- Monitor active trials, including subject enrollments/randomizations and study status updates.
- Ensure data quality and timeliness of institutional submissions.
- Resolve data-related issues, queries, and discrepancies in collaboration with study teams.
- Ensure Serious Adverse Events (SAE) reporting complies with protocol and NCI guidance.
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