+ Serveas the technical leader.
+ Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
+ Identify and implement solutionsto data management issues and concerns, incl uding proactive prevention strategies based on metricsand forecasts.
+ Serve as the project and client liaison incl udi ng provision of project specific data managementstatus, cycle time, and productivitymetrics.
+ Coordi nate and pa1ticipate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
+ Prepare data acquisition conventions and data review guidelines I diagnostic specificationsconsistent with the clinical data model, statisticalanalysis plans,and CRF (eCRF) completion I
monitoring conventions. Coordinatethe development and testing of data management system edit I datavalidation checks (diagnostics) and special l istings I procedures used as tools for the data review and discrepancymanagement activities.
+ Interact and collaborate with other project and specialtyteammembers (clinical operations,Biometrics, CDM technicalsuppmt, drug safety,etc.) to suppo1t the set-up, maintenanc e,and
closureof the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Maintain productivityand quality indicators.
+ Assist in the formulation of short-tennand long-term strategiesto improve peoject data management efficiencies, through collaboration with senior management.
+ Supervise, mentor and evaluate performan ce of staff to ensure career development,interpersonal skills, and achievement of competency standards.
- Oversee the technical performance of the staff on achievi ng client satisfaction through deliveryof quality data, on-time and on-budget.
- Mai ntain technical data managem entcompetencies via paitici pation in internal and external training semi nars.
- Assist with the development execution of training programs and ensure staffare trained andadhere to project-specific, global, standardized data management processes.+ Identify areas for process and efficiency improvement and implement solutionson assigned projects.
- + Suppo1trecruitment of new potential Data Management candidates.
- Support global standardization of data management processes and process improvement andefficiency and ensure standardsare applied at the local site.+ Create action plans to address staff quality and performance issues identified by clients, viaclient satisfactionsurveys, and/or from core project team feedback.+ Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.+ Review literature and researchtechnologies/procedures for improving global data management practices.
- + Suppmt business development for data management time and cost estimates and prepare andpresent to potential clients on global data managementcapabilities.
- + Manage utilization and billability of staff,planning for resource allocation I recruitment basedon individual skills, competencies, and availability.
- + Suppott development of global, harmonized SOPs and specific quality processes andprocedures for data management activities.
- Perform other duties as assigned by management.