Clinical Data manager
3 weeks ago
Data Management Specialist
We are looking for a meticulous and well-organized individual to supervise the handling of data discrepancies, study documentation, and various data management tasks. The ideal candidate should possess a robust comprehension of clinical data management processes and regulations, proficiency in data management systems and tools, and exceptional communication and coordination abilities.
Key Responsibilities:
- Supervise the management of data discrepancies
- Act as the custodian of study documentation, ensuring completeness and accuracy
- Compile content for the History of Science (HoS)
- Perform impact assessments for protocol amendments and complete necessary documentation
- Manage migration and audit trail reports
- Develop slides for study-specific EDC investigator training
- Provide study-specific training to data managers (DM)
- Contribute to the Data Management Plan (DMP)
- Request DTS creation and ensure completion for any LSH loads
- Execute data review per IDRP, including SAE reconciliation, PK reconciliation, short-term/long-term reconciliation
- Manage tables in EDC for study-specific inclusion/exclusion data
- Manage global and study-specific data entry conventions
- Facilitate versioning, including unlock/audit trail review and archival processes
- Provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design
- Communicate timely with key stakeholders on issues and risks
- Provide critical information to PL for communication with the study team
- Log action issues into DS Hub and resolve outstanding issues assigned to DA
- Manage assigned activities to meet milestone dates
- Ask questions to gather information needed to achieve end goals
- Manage programming-only changes and coordinate with DWA for LSH and SD
Requirements Requirements:
- Bachelor's degree in a relevant field
- Strong understanding of clinical data management processes and regulations
- Proficiency in data management systems and tools
- Excellent communication and coordination skills
- Ability to work effectively in a team and independently
- Attention to detail and strong organizational skills
- Knowledge of clinical trial protocols and procedures
- Familiarity with relevant industry standards and best practices
Requirements
Mortgage
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