Sr Clinical Data Manager

The Senior Clinical Data Manager reports to the Director, Clinical Programs & Clinical Operations and is responsible for executing and overseeing Clinical Data Management (DM) operational activities, ensuring compliance with protocols, timelines, good clinical practice, and regulations (US & EU).  In addition, they may oversee work of Clinical Data Analysts assigned to their study and data management services which are outsourced to data management partners, EDC, randomization, and imaging vendors in addition to data provided by Core Labs. 

Principle Duties and Responsibilities:

• Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget
• Coordinate and participate in the development of the clinical data model and/or database design according to protocol requirements and study specifications
• Represent Data Management and actively participate on Clinical Study Core Team meetings for all study activities
• Lead all DM functional activities using established templates/processes as applicable
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts including risk mitigation strategies
• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion/monitoring conventions
• Develops and test data management system edit/data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities
• Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
• Develops specification and collaborates with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study.
• Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan
• Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations
• Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary
• Assist in the creation and review of departmental SOPs, Work Instructions, and training materials