Puja Kumari

• Led business analysis for global clinical trial systems (Phase II–III), driving requirements and solution alignment.
• Gathered oncology protocol-driven requirements and translated them into BRDs, user stories, and functional specifications.
• Collaborated with Clinical Operations, Data Management, and Pharmacovigilance (PV) teams to align system workflows with study protocols.
• Supported configuration and enhancements of eClinical platforms (CTMS, eTMF, eCOA) to enable efficient trial execution.
• Supported oncology clinical trials, leveraging data analytics on patient and study data to identify trends, improve data quality, and support clinical decision-making.
• Executed UAT, CSV validation, and defect triage, ensuring compliance with GCP and 21 CFR Part 11.
• Facilitated Agile ceremonies and coordinated with global stakeholders (US/EU) for seamless delivery.

• Leveraged AI-driven analytics to generate insights for clinical development and trial optimization.
• Conducted clinical research analysis, feasibility assessments, and study design support for improved trial planning.
• Analyzed real-world data (RWD) and clinical datasets to enhance trial outcomes, patient stratification, and data-driven decision-making.

• Supported implementation of Clinion eClinical platforms (CTMS, EDC, IWRS) for clinical trials.
• Led requirements gathering workshops with sponsors and CROs, translating needs into functional specifications.
• Configured study-specific workflows aligned with clinical protocols and trial requirements.
• Executed UAT and validation activities, ensuring system readiness for study go-live.
• Ensured compliance with GCP, ICH guidelines, and regulatory standards.

Served as a Clinical Business Analyst, supporting patient-centric clinical trial solutions using Salesforce Health Cloud, with exposure to oncology therapeutic area studies. Led requirements gathering, workflow analysis, and process optimization, improving clinical data capture, patient engagement, and operational efficiency across clinical programs.

• Supported setup and configuration of Pharmacovigilance (PV) systems, aligning workflows for adverse event (AE/SAE) intake, case processing, and reporting with regulatory requirements.
• Gathered and translated requirements for PV processes, including case intake, MedDRA coding, and safety reporting, ensuring alignment with GCP and ICH guidelines.
• Collaborated with safety/PV teams and stakeholders to configure system workflows and ensure compliance with global safety regulations and reporting standards.
• Assisted in UAT and validation (CSV) of PV systems to ensure accurate safety data capture, traceability, and regulatory compliance.