Clinical Data Manager (perm)

Details: Clinical Data Manager with pharmaceutical industry exp needed in NJ • Act as lead data manager on multiple studies of moderate complexity with minimal supervision • Main point of client contact for all DM related matters • Execute all DM start-up activities, including the development and maintenance of • CRFs/eCRFs • Edit check and custom listing specifications • Data Management Plan • CRF Completion Guidelines • Conduct user acceptance testing of data outputs per DM specifications • Organize and actively participate in CRF review meetings with the client • Perform comprehensive hands-on data review of all patient data through query management and/or manual review in accordance with clients SOPs. • Analyzes study metrics to continually assess both data quality and study progress • Track and provide project status updates to project managers for monthly project team meetings • Coordinate with Quality Assurance team to resolve any QA data issues • May assist in the mentoring of less experienced employees • Manage and prioritize project deliverables per study timelines • Reconcile SAEs and work with drug safety • Ensure that data quality and integrity is maintained from study start through database lock • Work closely with CRA’s to address any negative data trends/issues specifically ahead of site visits • Provide ad hoc trainings to site members as needed • May assist the senior data manager based on study demands
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