Clinical Data Manager || Hyderabad, Bangalore, Kolkata, Mumbai, Pune

4 days ago

India 2COMS Full time

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

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