Danielle C. Email & Phone Number

Ipswich, Qld, Au

Reading, United Kingdom

Homebased

Maidenhead, Sl6 3Qh

• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities• Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent and quality clinical data• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts• Serve as the project and client liaison including provision of project specific data management status, cycle time, and productivity metrics• Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions• Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities• Advanced planning and risk management for projects (issue escalation, resource management)• Support recruitment of new data management candidates• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality• Supervise, mentor and evaluate performance of data managers in the location and aide in staff development, career development, interpersonal skills, and achievement of competency standards• Support the technical mentoring of data review staff in regional locations and aide in staff development, career developm