
Lead Clinical Data Specialist
2 days ago
Job Overview:
The Senior Clinical Data Coordinator role is a vital position within our organization, responsible for coordinating clinical data management activities. This involves working closely with project managers, data managers, and clients to ensure timely and accurate delivery of clinical data.
Key Responsibilities:
- Coordinate project-specific DMTMF (Data Management Trial Master File) and e-filing initiatives
- Develop and review project-specific documents, ensuring compliance with relevant regulations
- Handle client and team requests/issues in collaboration with project managers
- Facilitate UAT with CDA to guarantee robust database design
- Verify procedures as part of database validation processes
- Create, review, process, and track Data Clarification Forms and update clinical databases accordingly
- Conduct manual data listings as required
- Maintain documentation for Pre-production and Pre-lock audits, ensuring accuracy and completeness
- Provide project-specific training to junior staff members
- Support the Data Manager in their absence, handling day-to-day responsibilities
- Contribute to the development and review of departmental SOPs, ensuring alignment with organizational policies
- Perform basic QC functions for departmental activities, promoting quality and efficiency
- Ensure adherence to applicable rules, regulations, guidelines, SOPs, WIs, and policies throughout project deliverables
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