The Clinical Data Manager II is responsible for managing and coordinating all aspects of the data management process in support of research activities within the Infectious Disease Clinical Research Program. The incumbent will be a member of the Data Coordination Center, which is responsible for providing data processing and analytical support to the Infectious Disease Clinical Research Program. Responsibilities include study planning, development of CRFs and other data collection instruments, coordination of other DCC study team member activities, development and maintenance of the data management plan, data entry guidelines and coding manuals, generation and distribution of reports and data forms, data validation and data clarification resolution, and site training as needed for specific studies.
Interact with Clinical Research Managers and Principal Investigators to assess study needs and plan study activities
Lead a multi-functional team of data-related resources including data system programmers, data entry clerks, and SAS and Oracle programmers.
Work with project management staff to define timelines of assigned studies to ensure study milestones are met.
Represents Data Management (and the DCC generally) during study team meetings, regularly informing project management of overall study data status and potential issues for resolution.
Work with project management and DCC study team to determine data to be collected and to develop data collection instruments, including annotated documentation.
Develop and maintain study-specific Data Management Plans.
Develop and maintain study-specific Data Cleaning and Validation Plans.
Develop other study-specific documentation manuals including data entry instructions and guidelines, coding manuals and Standard Operating Procedures, as needed.
Perform EDC data collection instrument User Acceptance Testing.
Record the receipt, track and distribute research documents through the data management and verification process in a timely and accurate fashion.
Maintain files for storage of research documents.
Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles, status reports as well as any special purpose ad hoc reports.
Manage query submission, tracking and resolution for single complex studies or group of studies under direction of more senior data managers.
Review study databases for incomplete/missing data and other data issues.
Oversee the activities of other DCC staff assigned to manage studies.
Reconcile discrepancies and obtains guidance when values are questionable or illegible.
Interact with clinical personnel to resolve omissions, discrepancies or any other data management issues.
Mentor junior Data Managers on standards, DM practices and Quality Assurance practices.
Generate, distribute, track, enter resolution, annotate and file data entry reconciliation reports and data clarifications.
Verify computer-generated output against original data.
Check work for accuracy on a daily basis according to established procedures.
Report any system/data errors and/or problems to their supervisor.
Assist clinical users in database interaction as necessary, performing queries upon supervisor's direction.
Adhere to a policy of strict confidentiality concerning all documents, data, and information maintained within the department.
Adhere to department Standard Operating Procedures for all data management responsibilities.
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