Domain Consultant - Pharma

HEXAWARE•United States,

About The Position

This role involves acting as a Data Analyst and technical Subject Matter Expert (SME) within the Clinical business functional areas. The position requires documenting data transformation logic, collaborating with development teams to translate business logic into technical specifications, and partnering with the Clinical Operations team to understand business needs and identify strategic solutions. Responsibilities include evaluating business systems and user needs, consulting on business systems, planning, prioritization, and implementation of deliverables, and developing process documentation (current and future states). The role also entails documenting system, functional, and business requirements for Clinical initiatives, serving as a technical SME for clinical systems (e.g., eTMF, EDC, CTMS, IRT, MDM, Analytics), and coordinating support activities with vendors. Additionally, the position supports the identification and implementation of new Clinical solutions, manages external vendor relationships, troubleshoots operational and system issues, oversees vendor operational/maintenance and SLAs, and collaborates with Quality Validation and business stakeholders on Computer System Validation (CSV) impact, requirements, and artifacts. This includes supporting GxP CSV activities and managing associated documentation such as System Assessments, Validation Plans, User Requirements/Specifications, Testing Protocols and Scripts (IQ/OQ/PQ/UAT), Traceability Matrix, and Validation Summary Reports.

Requirements

Data analyst and technical SME in Clinical business functional areas.
Ability to document Data Transformation logic.
Ability to interact with development team to convert business logic into technical details.
Ability to partner with Clinical Operations team to understand business needs and identify solutions.
Experience in reviewing, analyzing, and evaluating business systems and user needs.
Experience in business systems consulting, planning, prioritization, and implementation.
Experience in developing process documentation (current and to-be).
Experience in documenting system, functional and business requirements, and objectives for Clinical initiatives.
Technical SME for clinical system(s), enhancements, and integration projects.
Experience coordinating support activities across vendor(s).
Experience supporting the identification and implementation of new Clinical solutions.
Experience interfacing with external vendors to manage relationships and ensure service delivery.
Ability to identify and troubleshoot operational issues and system issues.
Experience coordinating with Service team for vendor oversight and SLAs.
Experience collaborating with Quality Validation and business stakeholders on CSV impact, requirements, and artifacts.
Experience supporting GxP Computer System Validation activities.
Experience in computer system validation and change control documentation (System Assessments, Validation Plan, User Requirements/Specifications, Testing Protocols and Scripts (IQ/OQ/PQ/UAT), Traceability Matrix, Validation Summary Report).

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 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).
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.