Less than 5 years experience •
PURPOSE OF POSITION: Primarily to collaborate effectively with research team members through the design and development of clinical research data bases and quality processes, data cleaning programs and analytical datasets. Secondarily, assist in pre-analytical work through macro programming, adoption of external statistical programs for internal use, table creation and graph development.
·Data Quality and Standardization
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.
Collaborates with investigators, clinical research coordinators, statistical analysts and statisticians regarding the design, development and implementation of data management processes in clinical research studies. Develop new macros and/or adopt external statistical programs to facilitate other non-analytical programming needs (randomization code, graphs, matching code, etc.). May provide expertise and collaboration regarding case repot forms (CRFs), data dictionaries, and data management operations manuals.
·Reporting and Documentation
May create and maintain detailed data dictionaries and data management operation manuals for research studies. Creates summary tables, graphs, and listings for study coordination efforts via programming. Maintains clear documentation of all processes and procedures followed to produce all outputs.
Skills & Competencies
Practices Good understanding of good clinical practices (GCP), good clinical data management practices (GCDMP), clinical trial processes, and medical terminology.
Expertise in data quality programming, graphical displays, analytical datasets and macro programming. Good organizational and project management skills.
·Attention to Detail
Strong attention to detail and problem solving ability.
Required: ·Bachelor's degree in statistics, computer science, health sciences or administration, ·3 years related experience
Job Number: 97130