Clinical Data Science Lead

Tasks

• Adopt clinical data management technology improvements
• Develop KPIs metrics support
• Develop data integration specifications
• Develop data transfer specifications
• Drive continuous improvement initiatives
• Ensure TMF document archival and inspection readiness
• Ensure database data quality and on time delivery
• Lead EDC and clinical data tool setup
• Lead creation of data cleaning plan components
• Lead data review and query management
• Lead edit checks and listing review checks
• Lead interim and final database lock activities
• Maintain coding guidelines and SAE reconciliation guidelines
• Manage clinical data science activities for clinical trials
• Manage external data reconciliation
• Mitigate and resolve data management risks
• Oversee vendor deliverables
• Plan and manage external data management budgets and timelines
• Represent data management on clinical subteam
• Serve as first point of contact for CROs
• Support inspections and audits
• Support submission readiness
• Track study deliverables and study metrics

Perks/Benefits

• Annual leave
• Employee assistance program
• Flexible optional benefits
• Health insurance
• Life assurance
• Retirement planning
• Work-life balance

Skills/Tech-stack

Analysis Plans | CDISC | CRF | CTD | Clinical Data Management Systems | Clinical data | Clinical data management | Clinical trials | Coding Governance | Data Management | Data Management Systems | Data Validation | Data cleaning | Database lock | ECOA | EDC | EPRO | Edit checks | FDA Regulations | ICH regulations | IRT | Interim Database Lock | Management systems | Medical Dictionaries | Medical coding | Microsoft Office | NDA Submission | Query management | Relational databases | Statistical Analysis | Statistical analysis plans