Clinical Data manager

3 weeks ago


Kolkata, West Bengal, India 2coms Full time
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

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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