Pramod Prajapati

Experience

1. Product Technical Engineer

   Oracle

   Dec 2018 — Present · IN

   Client Handled: – (IQVIA, Novo Nordisk, GSK, Eli Lilly, Incyte, Pfizer, Eisai, etc)Product Handled -(Oracle InForm, IVRS, IRT, UMT, Central Coding, and InForm Adapter) Proactively handle problem tickets, performing RCA and resolve incidents within established SLAs. Documented system architecture diagrams, process flows, use cases, and other technical specifications. Worked closely with CROs, sites, and sponsor teams to ensure timely system access and issue resolution across multiple trials. Responsible for technical discussion with the clients, helping to resolve issue (understanding business impact). Delivered end-to-end technical support for clinical software applications including EDC used in Phase I-IV clinical trials. Maintain compliance with HIPAA regulations for secure transmission of sensitive healthcare data EDC platform like Oracle InForm. Knowledge of Good Clinical Practice (GCP), regulatory guidelines (e.g, FDA, EMA), and data privacy regulations. Experience with EDC systems like metadata Oracle InForm. Assisted with integration of lab data, patient randomization systems (IRT/IVRS) and clinical systems into trial platforms. Understanding of Micro-services, API Gateway, Authentication, OAuth and SSO. Collaborated with cross-functional teams (Clinical Operations, Biostatistics, etc). to support study setup, mid-study update and database lock. Engaged with stakeholders to ensure regulatory and compliance alignment (PCI-DSS) in authentication processes. Implemented Agile methodology best practices including Scrum. Supported API/EDI integrations for lab data and external system feeds into EDC. Requirement’s analysis, validation, and verification, ensuring that requirement statements are complete using JIRA. Facilitated UAT and coordinated defect triage for authentication and API-related features.

Skills

• Testing
• Integration
• Sql
• E-Commerce
• Product Management