SUBFUNCTION DEFINITION: Acquiring, validating, storing, protecting, and processing required data to ensure the accessibility, reliability, and timeliness of the data for its users.
???Database Management Designs, develops, and maintains databases in accord with established data management plans and GCDMP guidelines. Develops programs using statistical analysis system (SAS) language or other statistical software for the development of analytical datasets and reports. Develops rigorous quality control and quality assurance programs to perform data validation for data generated from clinical research studies and other databases to assure agreed upon data quality. Creates and follows standardized data quality processes to ensure reproducibility and increase efficiencies. May identify inconsistencies and discrepancies in data and takes the necessary steps to correct.
???Data Systems Collaborate with team members from various departments on the design, documentation, testing and implementation of clinical data management research systems studies. Develop systems for organizing data to analyze, identify and report trends. Design and maintain clinical databases. Designs and/or reviews Case Report Forms (CRFs). Develops process for incorporating laboratory and other external data. Develop, implement and maintain data management plans for clinical research studies programs of broad scope and complexity. Create and maintain detailed data dictionaries and data management documentation.
???Quality Assurance Analyze the interrelationships of data and define logical aspects of data sets. Integrate laboratory and other external data into database. Review final reports, tables, and listings. Create summary tables, graphs, and listings for clinical program staff and leaders and transplant administration staff and leadership. Develop computer programs to perform data validation and cross-form comparisons to check data completeness and accuracy using efficient and appropriate software. Track and reconcile, and enter when necessary, data forms received from program staff. Identify, clarify, and resolve data discrepancies. Participate in protocol reviews and identify critical data items required for analysis and reporting. Consult with senior peers on non-routine projects to learn through experience. Use rigorous quality control and quality assurance programs for data generated from clinical program databases to assure agreed upon data quality. Assure timely and accurate data submission to regulatory agencies.
???Reporting and Documentation Prepare reports for clinical programs for review of outcomes and for data validation . May evaluate and resolve issues regarding contents of reports. Collaborate with program staff and statisticians to prepare data sets for statistical analyses in mutually agreed upon formats. Generate summary tables meeting the needs of clinical program staff project/program coordinators. Oversee the development of case report forms, data entry guidelines, data management plans, and auditing and edit check guidelines for complex research studies. Retrieve, summarize, and report on study specific information on a timely and consistent basis for project, institution, and funding agency personnel for complex research studies.
???Leadership Mentor and train junior data management staff, clinical research coordinators and project managers regarding good clinical data management practices. Promote the use of good clinical data management practices across the institution through instructional seminars and to serve as a technical resource for the institution regarding good clinical data management practices. Build Organizational Capacity; Provide training to the organization on Good Clinical Data Management Practices. Develop, document, and provide training on standard processes for good clinical data management. Provide technical review for grants, protocols, data management plans, and manuals of operations regarding processes for data capture, data cleaning, data storage and data archival.
???Bachelor's degree in a related field ??? 5 - 7 years of work experience in a related job discipline.
Preferred: ???Certification in Clinical Data Management
At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better, and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.