Functional leadership with responsibility for delivering data management services to clients and project teams.
Management of clinical data vendors to achieve the productivity, quality, and timelines requirements of projects.
Maintaining optimal department processes and implementing excellent project-specific strategies.
Technical data management leadership or oversight on global, large and/or multiple projects with responsibility for the development of project Data Management Plan(s); data management systems set-up; and data accession, data entry and data review specifications and processes; and technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project(s) timelines and budgets.
Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.
Assist with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs to increase financial margins.
Responsibilities:
Serve as 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 solutions to 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.
Prepare 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
Interact and collaborate with other project and specialty team members (clinical operations, Biometrics, 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.
Maintain productivity and quality indicators.
Assist in the formulation of short-term and long-term strategies to improve project data management efficiencies, through collaboration with senior management.
Supervise, mentor and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of competency standards.
Oversee the technical performance of the staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
Maintain technical data management competencies via participation in internal and external training seminars.
Assist with the development and execution of training programs and ensure staff are trained and adhere to project-specific, global, standardized data management processes.
Support recruitment of new potential Data Management candidates. Identify areas for process and efficiency improvement and implement solutions on assigned projects.
Support global standardization of data management processes and process improvement and efficiency and ensure standards are applied at the local site.
Support development of global, harmonized SOPs and specific quality processes and procedures for data management activities.
Create action plans to address staff quality and performance issues identified by clients, via client satisfaction surveys, and/or from core project team feedback.
Manage utilization and billability of staff, planning for resource allocation / recruitment based on individual skills, competencies, and availability.
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.
Review literature and research technologies/procedures for improving global data management practices
Perform other duties as assigned by management.
Requirements:
Minimum seven (7) years relevant work experience in data management with four (4) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
Required to travel by plane and car.
Ability to drive and have a valid drivers license.
Overnight stays may be required.
Travel for internal meetings and symposiums.
Anticipated travel 10-20%.
Identify any language skills required or preferred of the position
The Senior Clinical Data Manager should demonstrate the ability to communicate fluently in both written and verbal English
