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Collaborates with cross-functional teams and facilitates the design, documentation, testing and implementation of clinical data collection studies in an electronic data capture (EDC) system
Creates and/or reviews study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner
Determines data collection requirements based on the study protocol and system knowledge, makes recommendations based on previous experience
Proactively identifies potential data management issues/risks and recommends/implements solutions
Manages data collection and data validation at participating clinical sites
Manages training documentation and provides oversight of system user access, may serve as resource for troubleshooting system issues
Creates and/or reviews study data management documents (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents)
Independently monitors own activities and project status for successful project deliverables according to timelines
Manages data reports and creates data summaries or presentations as applicable
Manages the development of the data validation plan and ensures associated edit checks are completed in accordance with project timelines
Manages and reconciles data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
Performs data review and query identification/resolution, manages data quality metrics for a protocol or project
Attends and contributes to project and functional group meetings, may serve as DM representative on external calls as required
Mentors staff on project-specific clinical data management processes, provides data management expertise at a project level
May provide direct line support for DM staff. For direct reports:
o Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
o Responsible for addressing employee relations issues and resolving problems
o Ensures DM salary and bonus equity compliance
o Approves timesheets, expense reports, and leave requests