Lead Clinical Data Managers
Remote, Home-Based in the USA or Canada
The selected candidate will serve as the technical leader on all data management aspects for project(s) including stait-up, maintenance, and completion activitie and develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Additional responsibilities include:
- Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.+ 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.I monitoring conventions.+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1t the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- 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.
- Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion
- Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
- Advanced planning and risk management for projects (issue escalation, resource management).
- Assist with goal creation and performance review assessment for data review project staff.
- Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.+ Support achievement of project revenue and operating margin for data management activities to agreed targets.
- Identify areas for process and efficiency improvement and implement solutions on assigned projects.
- Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
- Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
- Develop and maintain strategic client relationships and receive client satisfaction surveys and 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.