RAJAT KUMAR RAM
Summary
Clinical Data Programmer with proven 2 years experience supporting Obesity and Diabetes clinical trials at Novo Nordisk GBS. Expertise in EDC Systems Design and Data standards, and edit check development ensuring high-quality which aligned with GCP, CDISC, and FDA guidelines. Strong academic foundation from IIT Kharagpur and proven record in applying data science techniques to enhance clinical data management efficiency.
Overview
3
3
years of professional experience
1
1
Certification
Work History
ASSOCIATE CLINICAL DATA SCIENCE PROGRAMMER - EDC | Obesity & Diabetes
NOVO NORDISK GBS, BANGALORE
BANGALORE
11.2023 - Current
- Collaborate with Clinical Trial Development Managers, Standards Developers, SDTM Programmers, and Oracle Argus Safety teams to interpret clinical study protocols, define study requirements, and align on project timelines.
- Designed, developed, and validated robust Electronic Data Capture (EDC) systems using Oracle Inform, ensuring accurate, compliant, and efficient clinical trial data collection per GCP, CDISC, and FDA standards.
- Created and implemented edit checks, dynamic rules, and display overrides; troubleshot and resolved data integration, Argus mapping, and Oracle interface issues to maintain data consistency and integrity.
- Addressed User Acceptance Testing (UAT) feedback and provided post-production support, ensuring timely resolution of system issues and seamless clinical database integration.
- Experience with tools such as CDW, AMA, SmartChart, StudyBuilder, UNIX SCE, and COSMOS to design, review, and finalize study standards, aligning trial setups with Novo Nordisk (NN) standards.
SHORT TERM OPPORTUNITY | STANDARD DEVELOPER
NOVO NORDISK GBS, BANGALORE
BANGALORE
04.2023 - Current
- Developed and implemented clinical data standards across trial phases to ensure end-to-end data consistency, quality, and regulatory compliance from CRF design to final outputs.
- Collaborated with cross-functional teams during trial setup, protocol review, and metadata creation, generating and maintaining Protocol Metadata Documents (PMD) and supporting digital trial integration.
- Actively participated in PST, GST, and IG meetings, supporting CRF standard library implementation, risk mitigation, and efficient standardization of data collection processes across studies.
Education
M.TECH - Medical Imaging and Informatics
IIT Kharagpur
05-2023
B.TECH - Electronics And Instrumentation
C.V Raman Global University
Bhubaneswar09-2020
Skills
- Design and Build EDC Platform
- Edit Checks & Dynamic form design
- Unit and User Acceptance Testing(UAT)
- Connects Data with Standards
- Ensures Proper Data flow end to end
- Stakeholder Management
- Oracle Inform Central Designer
- Veeva EDC/CDB
- Study Builder
- MMA/CDW
- Microsoft Suite
CLINICAL DATA MANAGEMENT APPLICATION
CLINICAL TOOLS
Certification
- Certified in Veeva Vault CDMS Study Builder
- Certification of Data Science A-Z: Real Life Data Science Exercise UDEMY
- Hands on Experience & Certification in C++ from Coding Ninjas
- Hands on Experience &Certification in Python from simplilearn
Timeline
ASSOCIATE CLINICAL DATA SCIENCE PROGRAMMER - EDC | Obesity & Diabetes
NOVO NORDISK GBS, BANGALORE
11.2023 - Current
SHORT TERM OPPORTUNITY | STANDARD DEVELOPER
NOVO NORDISK GBS, BANGALORE
04.2023 - Current
M.TECH - Medical Imaging and Informatics
IIT Kharagpur
B.TECH - Electronics And Instrumentation
C.V Raman Global University
EXTRA CURRICULAR ACTIVITIES
Played for the Data Science Department team in the Novo Nordisk GBS 2025 Cricket tournament.