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**POSITION TITLE**: Lead Clinical Data Manager**REPORTS TO**: Manager or Director level Data Management or Designee**BASIC FUNCTIONS**:Lead Clinical Data Manager position is to manage all data management (DM) tasks for multiple projects from project start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.
**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:- Manages DM-related aspects of the project- Represents DM as the functional lead at internal and sponsor project team meetings- Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor- Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor- Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines- Works with DM program and/or administrative manager to provide resource and budget projections- Discusses roadblocks and proposed solutions for completing project objectives in a timely manner- Presents EDC and/or CRF completion at Investigator Meetings- Participates in regulatory and Sponsor audits for assigned study- Oversees daily team member activities- Serves as a Data Management team leader- Provides training of DM staff on project specific processes- Assures project activities are performed within budget and according to expected timelines and meet high quality standards- Reviews DM team member activities and deliverables to ensure plans and processes are followed- Oversees the DM project team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to:- Discrepancy management- Data Reconciliation (e.G