Clinical Data Standards Specialist

Greetings !

We are hiring for TCS Client !

Experience- 5+ Years

Location- Pan India (Remote)

Role:Clinical Data Standards Specialist

Strong hands-on Technical Clinical Data Management and Study Start-Up experience. Must have expertise in EDC/eCRF, Edit Checks, Data Listings, technical specification authoring/review, CDISC standards, and Clinical Data Standard Libraries. Experience with Veeva EDC, Veeva CDB, Medidata Rave, or Elluminate is preferred

Role Overview

We are looking for a detail-oriented Clinical Data Management professional with hands-on experience in Study Start-Up, EDC/eCRF development, Edit Checks, Data Listings, and Data Visualizations. The candidate should have strong technical knowledge of clinical data management specifications, CDISC standards, and Clinical Data Standard Libraries.

Key Responsibilities

• Review Standard Change Requests and conduct standard conformance assessments.
• Translate study requirements into reusable and standardized clinical data elements.
• Develop and maintain enterprise standards supporting study data cleaning and data quality.
• Create and review technical specifications, including:
  
• EDC System Specifications
• eCRF Specifications
• Edit Check Specifications
• Data Listing Specifications
• Standard Specifications and Metadata
• Perform test data entry and testing of developed standards.
• Support quality control reviews and contribute to standards documentation.
• Maintain and enhance Clinical Data Standard Libraries.
• Identify quality risks and contribute to continuous process improvements.
• Ensure compliance with clinical data standards and CDISC guidelines.