With continued mentoring by higher level data managers, is able to perform all data management activities for projects involving basic medical research studies supported by Department of Biostatistics. Has good understanding of Good Clinical Data Management Practices (GCDMP) and through mentors' review/feedback, implements them in their decision making process. Intermediate demonstration of SAS programming skills and demonstration of good communication skills.
Primary Duties and Responsibilities:
Reads grant proposals for small to medium size medical research projects. Reviews understanding of grant protocols with assigned mentor(s) and meets with the research team to clarify project requirements and timelines for data management activities. Work directly with investigators to create and edit Case Report Forms (CRFs) for this level of research projects. Determine the database structure for storage of study data and for projects of greater complexity, perform this activity under the mentoring of a higher level data manager.
With some oversight by assigned mentor(s), develop and test electronic data collection instruments along with relevant components within a database management system, i.e., REDCap, OnCore CTMS. Write SAS programs for performing QC of the study data collected. Prepares data status reports, compliance reports, and supports research team in the creation of study progress reports. Prepares interim and final analysis datasets, ensures tracking of database changes and completeness of documentation. Review deliverables with assigned mentor(s) and adjust accordingly.
Seeking input from assigned mentor(s), communicate with clinical investigators, study personnel, and project statisticians during the process of study design, data collection, and study closure to develop adequate data collection forms, resolve problems with the data, develop appropriate documentation for keeping the study team informed on the status of the database and provide timely datasets for analysis and statistical reporting to study statisticians.
Education / Work Experience
Combinations of related education and experience may be considered.
Bachelor degree from an accredited institution in Computer Science, Mathematics or a related field and six months of programming and database design experience. Two years of data management experience and ability to function independently in all aspects of clinical research data management from study start-up to study closure. Intermediate SAS and SQL experience.
Proficient communication skills.
Maintains a high degree of professionalism.
Demonstrated time management and priority setting skills.
Demonstrates a high commitment to quality.
Possesses flexibility to work in a fast paced, dynamic environment.
Seeks to acquire knowledge in area of specialty.
Working Conditions / Demands
Able to remain in a stationary position for extended periods of time and use office equipment. Able to communicate and participate in study meetings.
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.