Senior Associate, Data Manager, Clinical Data Sciences

Tasks

• Coach junior data managers and perform peer review
• Collaborate with Clinical Data Scientist to ensure operational excellence
• Coordinate database release and submission readiness
• Design and maintain databases and data collection tool specifications
• Develop and maintain Data Management Plan
• Document and share lessons learned for continuous improvement
• Ensure TMF documents are filed contemporaneously
• Ensure compliance with SOPs and GCP
• Lead clinical data management for trials
• Manage data cleaning and e data processing
• Manage data review and query management
• Oversee EDC based data acquisition standards
• Perform data access and visualization
• Report data management metrics

Perks/Benefits

• Hybrid work environment

Skills/Tech-stack

Clinical data | Clinical data management | Clinical trials | Data Management | Data Management Plan | Data Processing | Data Visualization | Data access | Data cleaning | Database Design | EDC | FDA Regulations | GCP | ICH Guidelines | MedDRA | Microsoft Office | Query management | SOP compliance | TMF | WHO Drug