Senior Clinical Data Manager

Duration: Ongoing rolling contract with extensions dependent on project work

Hours: Full time

Wage: Competitive

Job Description

The Senior Clinical Data Manager joins a team that ensures clinical trials collect useful, accurate, and reliable information. This involves designing data collection tools and data interpretation methodology with care, as well as closely integrating with other clinical study management functions.

Role Requirements

• Develop global Data Management Plans and Quality Management Plans to ensure the delivery of 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, managing and providing 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, annotating the CRF (eCRF) 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 systems (edit/data validation checks, diagnostics) and special listings/procedures used as tools for data review and discrepancy management activities.
• 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.
• Perform advanced planning and risk management for projects (issue escalation, resource management), overseeing the technical performance of the data review project staff to achieve 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.
• Identify areas for process and efficiency improvement on assigned projects.
• Support the achievement of project revenue and operating margin for data management activities to agreed targets.
• Lead experience across a variety of therapeutic areas.
• EDC experience, ideally with RAVE, and experience with other EDCs would be advantageous.
• Excellent oral and written communication and presentation skills.
• In-depth knowledge of the clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligations between the CRO industry and pharmaceutical/biotechnological companies.
• Ability to lead teams on project strategies and the achievement of department goals, objectives, and initiatives by example, encouraging team members to seek solutions.
• Experience with non interventional studies and RWE studies.

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