Responsibilities:

• Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to monitoring
• Interact and collaborate with other project and specialty team to suppo1tthe set-up, maintenance, and closure of the data management aspects of the project
• 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 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.
• 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 target
• Oversee the technical performance of the data review project staff 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
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

Requirements:

• 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 TCH 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
• 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 I biotechnological
• Demonstrated managerial and interpersonal skills