Data Scientist

• Lead end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live
• Review protocols to identify data collection requirements, build risks, inconsistencies, and impacts to database design or downstream processes
• Translate protocol requirements into study build specifications, including visit schedules, assessments, eCRFs, dosing, data collection, and edit checks
• Apply clinical data standards, including CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms
• Partner with the Standards team to implement protocol-specific modifications
• Collaborate with Study Execution Teams, Medical Data Review, Programming, Data Management, Standards, and other stakeholders
• Plan and oversee sandbox testing and user acceptance testing, including defect documentation, resolution, retesting, and system-readiness confirmation
• Manage timelines, dependencies, deliverables, risks, and issue resolution for database go-live
• Assess and manage the data management impact of protocol amendments and post-go-live changes
• Maintain accurate data management start-up documentation in the eTMF
• Ensure deliverables comply with SOPs, ICH-GCP, regulatory requirements, and internal quality standards
• Manage day-to-day clinical data science activities and support team delivery

Data Scientist jobs in Bulgaria

Lead Data Manager