Clinical Data Manager Ii
Current1. Participate in the cross-functional project teams as the lead clinical data manager.2. Provide input in the design of protocols, forms, and data collection processes.3. Create and maintain the following study specific documents:• Data Management Plans• Edit specifications• SAE Reconciliation Guidelines• Other plans and guidelines as required4. Ensure documents are provided according to established timelines and SOPs.5. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.6. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.7. Review and provide feedback on other study specific documents.8. Manage all data management activities of a clinical trial in the maintenance phase of the project.9. Provide project specific training on electronic data capture (EDC) and other data management systems to internal and external personnel.Problem SolvingEmployees in this position are required to discuss questions and suggestion for improvements with the study team priorto implementing new or modified study specific processes. The Clinical Data Manager II is expected to have a solidunderstanding of the regulatory framework as it relates to clinical research and data management, and be able toassess current and proposed processes for compliance with regulations and standards.