Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Designs and reviews Case Report Forms (CRFs). Assist in protocol review and development of study-specific data capture systems Act as a liaison and primary point of contact among clinical operations, statisticians, regulatory staff, and project level staff for all data management related issues and concerns.
Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports. Create case report forms, data entry guidelines, data management plans, and auditing and edit check guidelines. Retrieve, summarize, and report on study specific information on a timely and consistent basis for project, institution, and funding agency personnel.
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. Ensure accurate project-related databases through the timely generation of logic statements, querying of data, edit checks, resolution of inaccuracies and auditing of databases in accord with GCDM practices. Train study specific research personnel on appropriate data capture, storage, and quality control and testing procedures.
Analyzes the interrelationships of data and defines logical aspects of data sets. Processes laboratory and other external data. Reviews final reports, tables, and listings.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Lead the data management process for clinical research and outcomes projects.
Ability to work independently to develop, implement and manage projects; knowledge of the principles and concepts of project management including proficiency with relevant project management tools
·Good Clinical Practice
Knowledge of Good Clinical Practice (GCP)
·Medical Terminology - Intermd
Intermediate knowledge of medical terminology
·MS Office - Intermediate
Proficient in Microsoft Office programs
Strong organizational and project management skills to handle projects independently.
Ability to independently work through details of a problem to reach a positive solution
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.
Knowledge of good clinical data management practices (GCDMP) and clinical trial processes; expertise in creating relational databases, spreadsheets, and graphical displays. Ability to program with SAS.