The Data Manager within the ERGOMED Data Management (DM) is responsible for database testing, query management, management of lab reference ranges, serious adverse event reconciliation, vendor data reconciliation and other tasks related to data management. The Data Manager represents a position under direction of the Manager, Data Management and is supervised by the Project Data Manager on a project level.
The Data Manager is responsible for supporting various data management and EDC activities from initiation of protocol through database lock data cleaning activities including:
Study start-up
- Perform validation of EDC Systems and associated DM reports or listings
- Perform validation of EDC and SAS edit checks
- Manage and Create EDC user accounts
- Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
- Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
Study Conduct (Support multiple moderate complexity / complex trials with minimal supervision)
- May enter Data from trial documents into data entry system
- May perform Medical Coding
- Manage the entry, review, and tracking of Local/Central Lab reference ranges
- Attend internal/external teleconferences as needed
- May create and review study metric reports for internal/external project teams
- Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
- Provide the PDM with status updates on tasks that are assigned
- Escalates significant issues promptly to the study team
Study Closure
- Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports)
