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Senior Clinical Data Management Specialist
2 weeks ago
This is a senior-level position that requires a high degree of expertise in clinical data management. The successful candidate will be responsible for coordinating the day-to-day activities of the department, ensuring compliance with relevant regulations and guidelines.
Responsibilities:- Document Tracking and Control: Ensure accurate and timely tracking and control of project-specific and departmental documents.
- CRF Review: Conduct thorough reviews of CRFs and project-specific documents to ensure accuracy and completeness.
- Data Management Trial Master File (DMTMF): Develop and implement DMTMF and e-filing processes for projects, ensuring ongoing review and maintenance.
- Project-Specific Documents: Prepare project-specific documents, including reports and summaries, as required.
- Client and Team Coordination: Coordinate requests and issues from clients and team members, working closely with Project Managers to resolve concerns.
- User Acceptance Testing (UAT): Collaborate with CDA teams on UAT to ensure robust database design and functionality.
- Procedure Verification: Verify procedures as part of database validation, ensuring accuracy and integrity.
- Data Clarification Forms: Create, review, process, and track Data Clarification Forms to ensure data validity and integrity.
- Manual Data Listings: Conduct manual data listings as needed to support project deliverables.
- Document Maintenance: Assist in maintaining documents for Pre-production and Pre-lock audits, ensuring accuracy and completeness.
- Training and Development: Provide project and process-specific training to subordinates, enhancing their skills and knowledge.
- Data Manager Backup: Act as a backup for the Data Manager, ensuring continuity and stability.
- SOP Compliance: Ensure SOP compliance in project deliverables, adhering to regulatory requirements.
- Compliance and Quality Control: Perform basic QC functions for departmental activities, ensuring compliance with applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies.
This role requires strong organizational skills, attention to detail, and effective communication to ensure timely completion of projects. If you have a passion for clinical data management and are looking for a challenging opportunity, please apply.
