Mithra Jonnalagadda
Hyderabad
Summary
IT Professional with 12+ years of Life Sciences domain expertise in Clinical Trial Development, System Implementation, Integrations, Customization, Technical expertise on Medidata Rave, Designer & Oracle HSGBU products (Inform/Central Designer/ OC/RDC/TMS/LSH).
Overview
12
12
years of professional experience
Work History
Manager EDC Database Development
Bristol Myers Squibb
Hyderabad
01.2024 - Current
- Lead initial database development and oversee post-deployment modifications, with accountability for complex studies requiring advanced expertise.
- Successfully managed migration of studies from OC/RDC to Medidata Rave, ensuring the highest standards of data quality and validating system integrations.
- Build, maintain, and deploy study databases for clinical trial data collection, including configuration of internal modules (TSDV, Coder, Safety Gateway) and integration with external systems (IRT, EHR to EDC).
- Provided EDC technical expertise to Data Management and clinical study teams, enabling informed, data-driven decisions.
- Adhere to procedural documents and actively participate in their review and updates to align with industry standards, regulatory requirements, and best practices.
- Train and mentor new EDC Database Development team members on key activities and processes.
- Supported design and implementation of smart systems and optimized approaches, improving efficiency of data collection.
- Led continuous improvement initiatives to enhance electronic data capture capabilities across the organization.
- Collaborate with and review deliverables from external partners (e.g., CROs, technology providers, Function Service Providers) to ensure quality and compliance.
- Develop strong, strategic relationships with stakeholders across GDMCM, GDO, and BMS to support portfolio-wide objectives.
Senior Clinical Database Developer
Novartis Healthcare Private limited
Hyderabad
01.2022 - 01.2024
- Led database development for clinical studies using Medidata Rave.
- Implemented CDISC, SDTM & Novartis data standards for clinical studies.
- Managed data migrations and validations for clinical studies
- Collaborated with trial data managers, data standards, SAS programmers, and data transformation teams to develop new clinical studies from inception.
- Led projects and analyzed data to uncover improvement opportunities.
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Working on reducing Study Design time by improving Go/Accelerate
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork
Technical Support Engineer
Oracle
Hyderabad
09.2017 - 12.2021
- Executed study setup for EDC trials and provided technical support during fresh implementations and migrations.
- Diagnosed and resolved issues related to study deployment, including CD to InForm transitions, product performance, and data extraction.
- Engaged daily with customers to understand and analyze issues raised regarding HSGBU products.
- Provided guidance on installation and integration issues related to HSGBU products to on-premise clients.
- Performed root cause analysis of reported issues to decisively discern and enact corrections.
- Work closely with product development team on Bug-fixes and Enhancement Requests.
- Hands-on experience on Clinical Trial Development and Customization using Oracle's EDC (InForm), Central Designer.
- Experience in developing CRFs and Edit check development in Central Designer
- Experience on SAS Datasets, Base SAS, Data Step, Proc Step, Proc Compare reports generated as part of Post-migration Analysis, Data Validation, Change Management.
- Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation.
- Acquired strong skills in using SQL and PL-SQL for database management.
- Expert in writing complex Database Queries, Stored Procedures, Function, Triggers
- Monitor and Improve performance of database objects and SQL queries
- Develop Custom Reports, Dashboards in Cognos BI using Ad-hoc and Report Studio Functionality.
Associate Consultant
Techsol Systems India Pvt. Ltd.
Hyderabad
06.2014 - 09.2017
- Developed custom solutions to integrate data from various sources into OC/RDC/TMS, improving data accessibility.
- Developed custom reports aligned with client specifications, ensuring accurate and actionable insights.
- Proficient at Validating System and Data as per client's requirements.
- Insight knowledge on developing Validation and Derivation procedures(normal and Complex).
- Data Migration from different sources to Oracle Database.
- Facilitated client communication regarding incident resolution and report generation, enhancing client satisfaction.
- Creation of IQ (Installation Qualification) scripts and Change Management.
Education
Bachelor of Technology - Electronics & Communications Engineering
Krishna University
DMS SVH College Of Engineering05-2014
Skills
- EDC database development
- Electronic data capture
- Clinical trial design
- Database management
- Data migration
- SQL / PL-SQL / Mysql
- Oracle Database 11g,12c
- Sql Developer / Toad / OEM
- Data visualization
- Statistical analysis
- Risk assessment
- Project planning
- Stakeholder collaboration
- Technical documentation
Personal Information
Title: Technical Analyst
Timeline
Manager EDC Database Development
Bristol Myers Squibb
01.2024 - Current
Senior Clinical Database Developer
Novartis Healthcare Private limited
01.2022 - 01.2024
Technical Support Engineer
Oracle
09.2017 - 12.2021
Associate Consultant
Techsol Systems India Pvt. Ltd.
06.2014 - 09.2017
Bachelor of Technology - Electronics & Communications Engineering
Krishna University