Clinical Data Manager

Job Overview –
The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Additional responsibilities include:

• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.+ Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications/monitoring conventions, 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.
• 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 I diagnostic specifications 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.
• Advanced planning and risk management for projects (issue escalation, resource management).
• 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 targets.
• Identify areas for process and efficiency improvement and implement solutions on assigned projects.
• Maintain technical data management competencies via participation in internal and external training seminars.
• Oversee the technical performance of the data review project staff on achieving client satisfaction 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 as necessary.
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• Perform other duties as assigned by management.
• Review literature and research technologies/procedures for improving global data management practices.

Education Required:

• 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.

Experience Required:

• 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 and 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.