Medical University of South Carolina UNIV - Data Management Director DCU - Public Health Sciences (PHS) in Charleston, South Carolina
Job Summary: The Program Coordinator II will serve as the Data Management Director for assigned DCU studies.
Payscale Salary Range: UNIV-Band 6: $40,759.00 - $58,086.00 - $75,413.00 (min - mid - max)
25% - Serve as the Data Management Director for assigned DCU studies. Direct, implement, oversee, and manage all project specific data management activities for assigned projects. Provide comprehensive guidance and direction to collaborators pertaining to data management issues. - (Essential)
20% - Assess data management procedures with a focus on risk in accordance with the FDA policies and guidance on centralized monitoring and electronic health systems, and implement changes to ensure high quality data. (20%) 1.3 Conduct post-installation - (Essential)
15% - Direct and oversee the activities of external site monitors. Coordinate all necessary contractual and financial paperwork for monitoring activities, ensuring that all required monitoring can be completed within the allowed budget. Work with study team and coordinate with external monitors to ensure study-specific monitoring plan is followed appropriately. - (Essential)
15% - Conduct post-installation studies and evaluations. Ensure system meets the requirements of the end users. Review software data. Design and write SQL code for data cleaning procedures. - (Essential)
10% - Perform and document on-going end-user database system validation. This includes validating the data entry screens and other system modules (such as regulatory document, drug tracking, randomization, and monitoring) to ensure accuracy and appropriateness of data fields, data types, codelists, and validation rules. Troubleshoot web pages, check grammar and spelling, and verify links during database validation. - (Essential)
5% - Coordinate the planning and development of database systems. Maintain good relations with the sponsor officials, vendors and users. Consult with sponsors on software packages and hardware. This includes providing information regarding the capabilities of the software and customizing the software to meet the needs of the sponsor. Provide comprehensive guidance and direction to users regarding clinical database systems and data management processes including user hardware and software training. - (Essential)
5% - Evaluate system for accuracy, efficiency, and intuitiveness. Survey users, including principal investigators, enrolling sites, central pharmacists, adjudicators, and safety monitors, regarding software satisfaction. Relay information to IS team for consideration and implementation. - (Essential)
5% - Coordinate and lead internal study meetings. Prioritizes the work being conducted in a constantly changing environment. Provide information regarding resource allocation and needs within the unit. - (Essential)
Preferred Experience & Additional Skills:
Minimum Experience and Training Requirements: A bachelor's degree and two years relevant program experience.
Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)