BUDKUPAR RYNJAH

• Spearheaded cross-functional teams to enhance project delivery and data management lifecycle in regional and global clinical studies, achieving a desired increase in study efficiency by implementing innovative data management strategies
• Led the resolution of LIMS data transmission errors and programming gaps, ensuring GxP, GAMP 5 and CFR part 11 compliance, significantly reduced data discrepancies and improved data integrity
• Cultivated strong business relationships and facilitated knowledge-sharing sessions, leveraging diverse communication styles to meet project timelines and resolve issues, enhancing stakeholder satisfaction and fostering collaborative work environments
• Strong problem-solving skills and detail orientation
• Proven ability to establish strong client relationships
• Adopted robust Data Management practices that ensure data integrity and compliance for data acquisition and Clinical Data Management by clients and stakeholders

• Analyzed business and functional requirements to derive valid test cases.

• Carried out procedures to ensure that all information systems products and services meet regulatory standards and end-user requirements.

• Executed test scripts to validate Clinical Data Alignment, documenting test scenarios, defects, and resolution according to SDTM/CDISC standards.

• Defined master test plans to document overall testing strategy for a project.

• Provided risk assessment throughout test cycles and created lessons learned summary upon completion of project.

• Interpreted project requirement and technical design documents to stakeholders.

• Executed data alignment process
• Analyzed and validated clinical data using an IQVIA proprietary tool, ensuring accurate data transformation to SDTM standards
• Created and reviewed System Integration Plans for data alignment with multiple sources
• Managed and executed the data alignment process, facilitating efficient study setup and data integration
• Applied healthcare domain expertise to improve data quality and integrity

• Coordinated with multiple teams for software quality
• Conducted functional and system integration testing for insurance domain projects
• Coordinated with UAT teams, business analysts, developers, and end-users to ensure software quality
• Engaged in various testing methodologies, including V-Model, Waterfall, and Agile
• Contributed to robust testing strategies, enhancing system reliability for a globally used insurance tool
• Played a key role in executing comprehensive testing plans to ensure compliance with client requirements and industry standards