
Senior Medical Data Specialist
24 hours ago
Job Title: Senior Clinical Data Coordinator
">The role of a Senior Clinical Data Coordinator involves ensuring the smooth operation of project-specific and departmental document tracking and control activities. This includes reviewing CRFs (Case Report Forms) and project-specific documents, as well as initiating DMTMF (Data Management Transfer and Monitoring Form) and e-filing processes.
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- Track and control project-specific and departmental documents">
- Review CRFs and project-specific documents">
- Initiate project-specific DMTMF and e-filing">
- Prepare project-specific documents">
- Handle client and team requests/issues in coordination with the Project Manager">
- Coordinate User Acceptance Testing (UAT) with the CDA to ensure robust database design">
- Perform procedure verification as part of database validation">
- Create, review, process, and track Data Clarification Forms and update clinical databases for data validity">
- Conduct manual data listings as needed">
- Maintain Pre-production and Pre-lock audit documents">
- Provide project and process specific training to subordinates">
- Act as a backup for the Data Manager">
- Assist in preparation/review of departmental SOPs">
- Perform basic QC functions for departmental activities">
- Ensure SOP compliance in project deliverables">
Requirements:
">- ">
- Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies">
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