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 completion
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Perform quality control of data entry as needed
• Provide input, assess and manage timelines and resource needs for assigned projects
• 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
• 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 Trial Master File completeness
• Train clinical research personnel on study-specific CRF, EDC, and project-related items
• Review and query clinical trial data according to the Data Management Plan and perform line listing reviews
• Run patient and study level status and metric reporting
• Perform medical coding 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 QC of SAS programs used in Data Management when required
• Identify and troubleshoot operational problems based on metrics, audit reports, and stakeholder input
• Participate in protocol, SAP and CSR review and provide feedback when required
• Contribute to development and maintenance of SOPs and process documentation related to data management
• Attend strategy meetings, bid defenses, client engagements and provide leadership for cross-functional initiatives
• Train and ensure data management project team members are sufficiently trained
• Communicate with study sponsors, vendors and project teams regarding data, database or other project issues
• Present software demonstrations/trainings and department/company training sessions as needed
• May require some travel
• Perform other duties as assigned

Principal Clinical Data Manager

Junior Data Scientist

Data Scientist I, Real World Data Science

Data Scientist II

Data Scientist

Junior Data Scientist