Data Scientist

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring back-up, continuity, responsiveness, and timely task performance
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Perform or oversee quality control of data entry
• Provide input, assess and manage timelines; ensure clinical data management deadlines are met
• Assess resource needs for assigned projects as needed
• Develop CRF specifications from the clinical study protocol and coordinate stakeholder review/feedback
• Assist in building clinical databases and conduct database build UAT
• Maintain quality controlled database build documentation and oversee database quality
• Specify requirements for edit checks and oversee development of edit check and manual data review specifications
• Create, revise, version and maintain data management documentation and ensure completeness for the Trial Master File
• Train clinical research personnel on study specific CRF, EDC, and other project items
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review per sponsor or Lead DM guidance
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaise with third-party vendors (external data and EDC vendors) in a project-manager capacity
• Assist with SAS programming and quality control of SAS programs used in Data Management
• Identify and troubleshoot operational problems based on metrics, audit reports, and team input
• Assist in reviewing and providing feedback on protocols, SAP, and CSRs if required
• Participate in SOP development and maintenance related to data management and database management
• Attend strategy meetings, bid defense prep, bid defenses, capability presentations, and potential client engagement meetings
• Review RFPs, proposals and provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives and train project team members
• Communicate with study sponsors, vendors and project teams regarding data, database or project issues
• Present software demonstrations/trainings, department/company training sessions, and present at project meetings
• May require some travel
• Perform other duties as assigned

Senior Clinical Data Manager

Data Scientist

Project Data Manager – Romania, Poland, Hungary, Slovakia, South Africa

Data Scientist III

Data Scientist