Job Description

: 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

• Bachelor