Data management leadership on global, large and/or multiple projects with responsibility for the development of the project Data Management Plan; data management systems set-up; and data accession, data entry and data review specifications and processes; and oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project 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.
• Management of clinical data vendors to achieve the productivity, quality, and timeline requirements of projects.
• Serve as the technical leader on all data management aspects for project(s) including start-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 forecasts.
• Serve as the project and client liaison including management and 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 (eCFR) according to these specifications.
• Review 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.
• Advanced planning and risk management for projects (issue escalation, resource management).
• Support recruitment of new data management candidates.
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, 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.
• Supervise, mentor and evaluate performance of data managers in the location and aide in staff development, career development, interpersonal skills, and achievement of competency standards.
• Support the technical mentoring of data review staff in regional locations and aide in staff development, career development, interpersonal skills, and achievement of competency standards.
• Oversee the technical performance of the data review project 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.
• Ensure project 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 margin for data management activities to agreed targets.
• 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.
• Minimum six (6) years relevant work experience in data management with approximately three (3) years technical supervisory experience to include data management, clinical operations, knowledge of several therapeutic areas.
• Demonstrated skill for technical management of staff exceeding 10 employees.
• Financial management of gross revenues in excess of $500K per year.
• Excellent oral and written communication and presentation skills.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
• Demonstrated ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
• Demonstrated managerial and interpersonal skills.
• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Additional relevant work experience will be considered in lieu of formal qualifications.
• Broad knowledge of drug development process.
• Understanding of global clinical development budgets and relationship to productivity targets.
• Thorough knowledge of effective clinical data management practices.
• Thorough knowledge of time and cost estimate development and pricing strategies.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
Job Number 2018-20875