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 (eCRF) according to these specifications.
Review data acquisition conventions and data review guidelinesIdiagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion monitoring conventions.
Coordinate the development and testing of data management systems editIdata validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
Interact and collaborate with other project and speciality team members (clinical, programming, statistics, CDM technical support, drug safety, ) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
Advanced planning and risk management for projects(issue escalation, resource management).
Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
Assist with goal creation and performance review assessment for data review project staff.
Maintain technical data management competencies via participation in internal and external training seminars.
Ensure project staffs 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.
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 processes.
Understanding of global clinical development budgets and relationship to productivity targets.
Knowledge of effective clinical data management practices.
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
Minimum five (5) years relevant work experience in data management with approximately one (1)year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
Demonstrated skill for technical management of staff exceeding 5 employees.
Financial management of gross revenues in excess of $250K per
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 operation
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical I biotechnological companies
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