I help clinical teams manage trial data from study start-up to database lock, so the numbers your statisticians and regulators see are clean, traceable, and standards-aligned.
Across the study lifecycle
- Start-up: Data Management Plan, CRF/eCRF and annotated CRF design, edit checks, and User Acceptance Testing.
- Conduct: data entry and validation in the EDC, query and discrepancy management, AE/SAE/ConMed/lab reconciliation, and vendor data reconciliation.
- Closeout: medical coding sign-off, database lock, and closeout documentation with a full audit trail.
Standards and compliance
Work follows CDASH and SDTM data standards under ICH-GCP, 21 CFR Part 11, and GDPR. Medical coding uses MedDRA and the WHO Drug Dictionary.
Tools and automation
Trained on EDC platforms including Medidata Rave and Veeva. Where it saves time and cuts error, I automate SDTM mapping and clinical data reporting in R, including the {sdtm.oak} package.
Background
I completed a deep-dive Clinical Data Management course, basics to advanced, and passed its exam, covering the full lifecycle above. This sits on top of hands-on training in clinical data reporting and SDTM dataset creation in R, and years of work in regulated MedTech and pharma environments.