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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)
Bachelor's Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline
4-8 years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment
Employment type
Full-time
Work arrangement
Yes
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