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Title:Sr. Manager, Clinical Data Management
Salary:Open
Experience:7+
Location:NJ - Princeton

Description:
  • 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

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