Summary Highly skilled medical doctor with more than 15 years medical knowledge in various therapeutic area. 5 years' experience as Clinical Data Manager ensuring that data for clinical trials is properly collected, validated and clean. Diligently evaluate data, verify results and present conclusions. Excellent track record when it comes to consistent quality and reliability in carrying out research duties according to regulatory guidelines. * Various therapeutic area knowledge * Clinical data management software: Oracle Clinical 4.6, Oracle Clinical Remote Data Capture 4.6 * Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, * Broad knowledge of the clinical development process and GCP/GMP/ICH * Phase I - IV participation in the clinical study startup phase, conduct phase activities through to database lock and freeze phases * Data validation and derivation procedure * Edit check implementation and testing * Creation of Data Management Plans, SOPs * Case Report Form preparations * Validation test implementation * Data collection methods * Discrepancy management * ICH and GCP guideline

Highlights:

• Coding
• Data Management
• Data Quality
• Database
• Management
• Quality
• Quality Assurance
• Data Analysis
• Data Entry
• Oracle