Clinical Data Manager - Remote

Job Responsibilities
Responsible for Clinical Data Management activities for assigned studies:

• Act as a Clinical Data Manager for assigned data management projects
• Act as a Project Lead for Biometric-only projects (as needed) (Lead specific)
• Coordinate work of other Clinical Data Management staff assigned to the project (Lead specific)
• Review Study Protocol
• Develop CRF or review of sponsor-generated CRFs
• Develop Database
• Define and program edit checks
• Responsible to prepare, finalize and archive all related DM documentation
• Develop Data Management Plan and Data Management Report
• Develop Data Validation Plan (including definition of edit checks
• Develop Data Entry Instructions/ eCRF completion guidelines
• Coordinate validation of database, edit checks and trial and site settings
• Performs validation of database, edit checks and trial and site settings in studies where not the responsible CDM
• Perform CRF handling including logging, tracking and sorting
• Support the CRAs in study related questions
• Perform Data cleaning and query handling
• Ensure completion of Quality Control task for the finalization and transfer of the study database and related documents to the sponsor
• May coordinate SDTM mapping with the senior programmer when needed
• Carry out all tasks related to database closure
• Provide CDs with study documentation to the sites (patient data, audit trail and closed queries)
• File/archive essential documents
• Provide metrics and status updates to senior management and project leaders and sponsors if required
• Train and support Clinical Data Associates and Clinical Data Managers
• Train and support both internal and external Clinical Study Teams
• Represent Data Management in sponsor and investigator meetings
• Responsible to escalate any issues on projects or the need for potential SOP deviations
• May perform system validation, create test scripts for system validation as well as perform UAT of ePROs in collaboration with the CRA
• Actively contribute to the organization and development of processes to enhance the work
• May provide input into proposals which include Data Management and attend Bid Defense meetings face-to-face or via webex (Lead specific)