Clinical Data Manager

Summary

Results-driven Senior Clinical Data Manager with a Master's degree in Digital Project Management and a solid 10-year background in the pharmaceutical industry. Demonstrated expertise in overseeing and executing clinical data management activities, ensuring accurate and high-quality data for clinical trials. Committed to leveraging digital project management principles to optimize processes and drive project success.

Expectations

As a Senior Clinical Data Manager, expectations include leadership in data management, adherence to regulatory standards, team mentorship, project coordination, strategic input, stakeholder communication, and driving excellence in clinical trial data practices

Employment Preferences

Expected Base Salary

**,000 EUR

Academic Degree

Experience

Skills

• Clinical Data Management
• CDISC Standards
• Data Cleaning
• Database Programming
• Electronic Data Capture
• EDC
• Clinical Trial Data
• Protocol Development
• Data Validation
• Quality Control
• Data Analysis
• Clinical Study Reports
• Regulatory Compliance
• Risk Management
• Clinical Database Design
• SAS Programming
• Medical Coding
• MedDRA
• WHO Drug
• CRF Design
• Data Reconciliation
• Project Management
• Leadership
• Team Management
• Clinical Research
• GCP
• Good Clinical Practice
• SOP
• Standard Operating Procedures
• FDA Regulations
• ICH Guidelines
• Data Monitoring Committee
• DMC
• Data Collection Tools
• Vendor Management
• Statistical Analysis Plan
• SAP
• Interdisciplinary Collaboration
• Pharmacovigilance
• Data Privacy
• Security
• Clinical Data Standards Implementation
• Query Management
• Clinical Database Lock
• Study Start-Up
• Clinical Data Review
• CDASH
• Clinical Data Acquisition Standards Harmonization
• Risk-Based Monitoring
• RBM