At least 3 years of Core Clinical Data Management (CDM) experience, including 2+ years of external data handling and reconciliation (Lab & ECG). The ideal candidate should have hands-on experience with Medidata Rave EDC and be experienced in managing study activities from start-up through database lock.
- Data listing review and query management
- User Acceptance Testing (UAT)
- External data reconciliation (Lab & ECG)
- Preparation of study-specific reports
- Database freeze and lock activities
- Review of vendor data transfer agreements/specifications
- Quality control (QC) of listings and closed queries
- Filing and maintenance of study documentation in eTMF
- Support study closeout activities and other assigned responsibilities
- Ensure adherence to applicable SOPs, GCP guidelines, and regulatory requirements.
- Perform additional duties and responsibilities as assigned.