+ Serve as the technical leader on all data management aspects for project(s) including stait-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
+ Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
+ Coordinate and paiticipate i n the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
+ Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completionI monitoring conventions.
+ Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1tthe set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handlingand quality.
+ Advanced planning and risk management for projects (issueescalation, resource management).
+ Oversee the technical pe1formance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
+ Assist with goal creation and performance review assessment for data review project staff.
+ Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
+ Ensureproject staff are trained and adhere to project-specific, global, standardized data management processes.
+ Identify areas for process and efficiency improvement and implement solutions on assigned projects.
+ Support achievement of project revenue and operating marginfor data management activities to agreed targets.
+ Develop and maintain strategic client relationshipsand receive clientsatisfaction surveysand implement appropriate action plans as necessary.
+ Support business development for data management time and cost estimates and
prepare and present to potential clients on global data management capabilities.
+ Perform other duties as assigned by management.
+ Review literature and research technologies/procedures for improving global
data management practices.