Note: The job is a remote job and is open to candidates in USA. Hexaware Technologies is seeking a Domain Consultant specializing in Pharma to act as a data analyst and technical subject matter expert in clinical business functional areas. The role involves documenting data transformation logic, partnering with clinical operations, and managing business systems consulting and implementation deliverables.

Responsibilities

• Represent DDI as the Data analyst and technical SME in the Clinical business functional areas
• Document Data Transformation logic and interact with development team to convert business logic into technical details
• Partner with ClinicalOperations team to understand business needs and identify solutions that align to overall business strategies
• Review, analyze and evaluate business systems and user needs
• Responsible for business systems consulting, planning, prioritization, and implementation of deliverables, including implementations and operations
• Develop process documentation (current and to-be)
• Document system, functional and business requirements, and objectives for Clinical initiatives
• Technical SME for system activities for the clinical system(s), enhancements, and integration projects
• Coordinates support activities across vendor(s)
• Systems include but are not limited to eTMF, EDC, CTMS,IRT, MDM and Analytics
• Support in Identification and Implementation of new Clinical solutions
• Interfaces with external vendors at all levels to manage the relationship and ensure the proper delivery of services
• Identify and troubleshoot operational issues and system issues
• Coordinate with Service team to provide oversight of vendor operational/maintenance and SLAs
• Collaborate with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts
• Support in GxP Computer System Validation activities for DDI, including implementation, validation, maintenance
• Responsible for computer system validation and change control documentation including - System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (IQ/OQ/PQ/UAT), Traceability Matrix, Validation Summary Report

Skills

• Represent DDI as the Data analyst and technical SME in the Clinical business functional areas
• Document Data Transformation logic and interact with development team to convert business logic into technical details
• Partner with Clinical Operations team to understand business needs and identify solutions that align to overall business strategies
• Review, analyze and evaluate business systems and user needs
• Responsible for business systems consulting, planning, prioritization, and implementation of deliverables, including implementations and operations
• Develop process documentation (current and to-be)
• Document system, functional and business requirements, and objectives for Clinical initiatives
• Technical SME for system activities for the clinical system(s), enhancements, and integration projects
• Coordinates support activities across vendor(s)
• Systems include but are not limited to eTMF, EDC, CTMS, IRT, MDM and Analytics
• Support in Identification and Implementation of new Clinical solutions
• Interfaces with external vendors at all levels to manage the relationship and ensure the proper delivery of services
• Identify and troubleshoot operational issues and system issues
• Coordinate with Service team to provide oversight of vendor operational/maintenance and SLAs
• Collaborate with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts
• Support in GxP Computer System Validation activities for DDI, including implementation, validation, maintenance
• Responsible for computer system validation and change control documentation including - System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (IQ/OQ/PQ/UAT), Traceability Matrix, Validation Summary Report

Company Overview

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