BUGATHA MANISHA REDDY
Bengaluru
Summary
Clinical Data and Statistical Programming professional with 5.5+ years of experience supporting clinical studies across data services, SDTM programming, and data design. Strong expertise in CDISC SDTM, GCP, SQL, clinical data validation, and clinical data lifecycle management. Demonstrated ability to ensure high data quality, support regulatory-compliant deliverables, and collaborate effectively with cross-functional clinical teams.
Overview
5
5
years of professional experience
Work History
Clinical Data Services Senior Analyst
Accenture
Bengaluru, Karnataka
06.2024 - Current
- Maintained compliance with GCP, GDP, and study SOPs to uphold the accuracy and integrity of clinical trial data.
- Analyzed data discrepancies and facilitated query resolution for enhanced study integrity.
- Oversaw SDTM-compliant data standardization processes to ensure optimal preparation for statistical analysis and reporting.
- Executed data extraction, reconciliation, and validation processes using SQL to ensure accuracy of clinical datasets.
- Utilized Oracle DMW and clinical data platforms to streamline data cleaning and support comprehensive lifecycle activities.
- Engaged with data management, statistical programming, and clinical operations teams to troubleshoot and rectify data issues.
- Implemented strategies to enhance data quality and streamline study delivery processes.
Clinical Data Programming Scientist
Accenture
Bengaluru, Karnataka
09.2021 - 05.2024
- Conducted thorough validation of SDTM datasets, adhering strictly to CDISC implementation guidelines.
- Oversaw the complete study setup, focusing on precise mapping and transformation of dataset specifications.
- Conducted comprehensive validation and quality control assessments of clinical data to guarantee compliance with regulatory guidelines.
- Partnered with statisticians and data managers to facilitate successful execution of clinical study objectives.
- Utilized structured analysis and programming logic to resolve intricate data issues and discrepancies, ensuring data integrity.
- Developed and applied standardized coding practices to streamline operational processes.
- Coordinated timely completion of study milestones to uphold rigorous data quality benchmarks.
Data Design Analyst
Accenture
Bangalore Urban, Karnataka (Remote)
08.2020 - 08.2021
- Led data mapping projects to align data structures with business objectives. Oversaw collaboration between departments to ensure accurate data representation. Championed best practices in data mapping to improve overall data quality.
- Coordinated clinical data design and study setup efforts to enhance operational efficiency.
- Collaborated in establishing data structures and specifications aimed at meeting protocol standards.
- Conducted thorough evaluations of data sets to uphold integrity and reliability standards.
- Streamlined communication with stakeholders to enhance data integration and flow across clinical systems.
Education
Bachelor of Science - Computer Science Engineering
Gopalan College of Engineering & Management
Bengaluru, India05-2019
Skills
- Project Management Coordination
- Stakeholder Management
- Client relationship management
- Effective troubleshooting abilities
- Cross-Functional Collaboration
- Clinical Data Management
- Data programming in clinical research
- Standard Data Tabulation Model (SDTM)
- Proficient in CDISC standards
- Proficient in GCP services
- SQL data analysis
- Experience with Oracle applications
- Data management and warehousing (DMW)
- Clinical Data Tools
Accomplishments
- Core Values Awards - 2021, 2022, 2023
- Business Excellence Award - 2024
Timeline
Clinical Data Services Senior Analyst
Accenture
06.2024 - Current
Clinical Data Programming Scientist
Accenture
09.2021 - 05.2024
Data Design Analyst
Accenture
08.2020 - 08.2021
Bachelor of Science - Computer Science Engineering
Gopalan College of Engineering & Management