Clinical Data Manager I
Current- Serve as primary CTI Clinical Data Management contact with sponsors and represents CDM on CTI project teams - Responsible for study-specific CDM document development and maintenance - Responsible for project status reporting to the CTI project team, CDM management, and sponsors. - Responsible for data cleaning process from start-up through data archival - Develop and/or approve project database builds, testing, and validation - Coordinate receipt and processing of information for projects (e.g., coding dictionaries) and third-party electronic data utilized on projects - Perform and/or direct activity of CDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from study start-up through archival - Develop and maintain study-specific documents including Case Report Forms, CRF Completion Guidelines, Clinical Data Management Plan, Annotated CRFs, and Edit Specifications - Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action; seek out existing knowledge prior to developing new methods - Monitor the quality of work performed by the CDM project team and compliance with GSOPs and provide feedback to the team - Develop project reports which meet the needs of sponsors, project team, and CTI management, which are accurate, and are provided to the sponsor and CDM management upon request or per a predefined schedule - Coordinate receipt and handling of data received from external sources and direct reconciliation where applicable - Maintain current study-specific documentation to accurately reflect process deviations and changes in project assumptions or the scope of contracted work - Conduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to CDM management
