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Domain Consultant - Pharma at HEXAWARE

, , United States -

Full Time

Start Date

Immediate

Expiry Date

18 Sep, 26

Salary

0.0

Posted On

20 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Analysis, Technical SME, Business Systems Consulting, Process Documentation, Computer System Validation, GxP, Clinical Operations, Vendor Management, Requirements Gathering, Change Control

Industry

IT Services and IT Consulting

Description

"• 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.

Responsibilities

Acts as a technical SME and data analyst to bridge the gap between clinical business needs and technical implementation. Responsible for documenting data transformation logic, managing clinical systems, and overseeing GxP computer system validation activities.