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sas cdisc irt ecoa meddra📋 Description
- Ensure regulatory, ICH, GCP, SOP, and CDM best practices compliance.
- Lead data management study communications as primary contact.
- Lead EDC development: CRF, specs, edit checks, and UAT.
- Review CRO data documents: DM plans, validation specs, guidelines.
- Ensure data quality in EDC and other databases; raise issues.
- Lead DM deliverables (DMC snapshots, database locks) with CRO vendor.
🎯 Requirements
- Bachelor's degree in life science, CS, or related field.
- 5+ yrs CDM / 8+ yrs Sr CDM in pharma/CRO; Phases I-III.
- Proficient in web-based EDC systems (Medidata Rave, Oracle InForm).
- Knowledge of ICH, FDA, and GCP regulations.
- CDISC/CDASH/SDTM standards knowledge.
- Proficient in Word, Project, PowerPoint, Excel.
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