Aarati Hegde
Edison,NJ
Summary
Motivated programmer with 11+ years of commended performance in building and testing clinical trial databases while working with pharmaceutical companies and Clinical Research Organizations(CROs).
Overview
13
13
years of professional experience
1
1
Certification
Work History
Sr. Manager EDC Database Development
Bristol-Myers Squibb
03.2022 - 02.2024
- Design, Build, maintain, and deploy clinical study databases along with module connections and external system integrations to collect clinical trial data for 15+ studies.
- Serve as the EDC SME providing oversight for database build-related activities
- Work with all external data vendors to ensure proper integration of the data.
- Mentoring newer EDC Database Development team members on key activities and processes.
- Supports Data Management, Statistical Programmers, and Clinical staff in the ongoing maintenance and updates to the databases and corresponding documentation.
- Interact with project team members with a positive attitude, promoting and contributing to a good company culture with a productive and professional environment.
- Good time management and organization skills; the ability to work efficiently and prioritize tasks to meet tight deadlines while maintaining the highest standards of work.
Clinical Programmer (Consultant)
Celgene Bristol-Myers Squibb
09.2017 - 03.2022
- Accountable for EDC database development, testing, and maintenance until the database is locked by company standards.
- Deeply involved in cross-functional team interactions to understand each function's needs.
- Developed several data transfer specifications based on company standards and acted as a liaison between vendors to maintain quality.
- Provide oversight of CROs/vendor programming activities to ensure adherence to standards as well as receiving quality and timely deliverables.
- Processed data extracts by standards to be delivered to Biostatistics and statistical programming.
Programmer Analyst
ITS Analytics, INC
01.2017 - 08.2017
- Extensively worked on edit check programming and supported Data Management in creating Logic Specs in cleaning data.
- Verified accuracy and integrity of Clinical data by performing validation checks and data cleaning by investigating data-related errors and missing values.
- Interacted with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.
Lead Programmer/Programmer Analyst
Quintiles
08.2013 - 05.2015
- Scheduled and active member in various study initialization meetings like kick-off and provided technical expertise in conjunction with internal and external clients.
- Created study and environment setup per core configuration.
- Developed Edit checks, Custom Functions, and Derivations for the data fields as per the specifications in the Data Management Plan.
- Generated various study-specific reports using the Reporter module.
- Provided Risk Analysis, Impact Analysis, and possible amendments to the database.
Clinical Programmer
Theorem Clinical research
05.2011 - 05.2013
- Expertise in Rave Study Build/Designing, Amendment Manager, Core Configuration, Report.
- Maintained good communications and working relationships with teams and external clients.
- Developed Edit checks, Custom Functions, and Derivations for the data fields as per the specifications in the Data Management Plan.
- Provided technical support as SME for all Custom Function activities.
- Monitor quality and efficiency across projects to identify trends and opportunities for improvements.
Education
Bachelor of Engineering -
Vishwesvarayya Technological University
01-2010
Skills
- EDC Database: Medidata RAVE EDC , Medidata Classic,eCase Link
- Programming: Custom Function -C#, SAS, SQL
- Tools: MS Project, MS Excel, IRT, Veeva Vault TMF, JIRA (Incident management tool), GBDS Milestone and Tracking System (GMAT), Microsoft Visual Studio
- Rave integration Modules: Safety Gateway, ePRO, TSDV, Reports, and SAS on Demand
Certification
- Medidata RAVE Certified study builder
- SAS Certified Base Programmer for SAS 9
- Drug Development, University of California, San Diego on Coursera.
- PMP Certification- training in progress
Therapeutic Areas
- Cellular Therapy(CAR-T, NEX-T)
- Hematology
- Oncology
- Cardio Vascular
- Neuroscience
Clinical Knowledge
- ICH-GCP guidelines
- 21CFR part11
- Coding Dictionary (MedDRA/WHO drug)
- CDASH
- CDISC
- SDTM
- HA Inspection readiness
Timeline
Sr. Manager EDC Database Development
Bristol-Myers Squibb
03.2022 - 02.2024
Clinical Programmer (Consultant)
Celgene Bristol-Myers Squibb
09.2017 - 03.2022
Programmer Analyst
ITS Analytics, INC
01.2017 - 08.2017
Lead Programmer/Programmer Analyst
Quintiles
08.2013 - 05.2015
Clinical Programmer
Theorem Clinical research
05.2011 - 05.2013
Bachelor of Engineering -
Vishwesvarayya Technological University
- Medidata RAVE Certified study builder
- SAS Certified Base Programmer for SAS 9
- Drug Development, University of California, San Diego on Coursera.
- PMP Certification- training in progress
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