Clinical Data Manager

Clinical Data Manager

The CDM will be responsible for developing data management plans and quality management plans that will deliver accurate, timely, consistent and quality clinical data.

Responsibilities:

• 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 to CROs 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 designs and annotate the CRF (eCRF) according to the 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
• 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
• Be responsible for advanced planning and risk management for projects (issue escalation, resource management)
• Oversee the technical performance of the data review project staff at CRO through delivery of quality data, on-time and on-budget
• Assist with objectives for data review by CRO
• Maintain technical data management competencies via participation in internal and external training seminars
• Oversight of CRO staff training and adherence to project-specific, global, standardized data management process
• Collaborate with CRO on areas for process and efficiency improvement and implement solutions on assigned projects
• Review literature and research technologies/procedures for improving data management practices for the Company in collaboration with CRO
• Perform other data management duties such user acceptance testing, data listing reviews, data trend reporting, timeline confirmation for database lock, etc.

Education/Qualification:

• Bachelor’s degree in business, computer science, math, science or a related field
• 5+ years relevant experience in a CRO, biotechnology or pharmaceutical company
• Broad knowledge of the drug development process
• Understanding of global clinical development budgets Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
• Knowledge of SAS preferred
• Knowledge of time and cost estimate development and pricing strategies for data management services, EDC vendor selection, ancillary database transfers
• Ability to manage multiple projects/priorities
• Excellent oral and written communication skills