Pavan Kumar Reddy Itikyala Mulinti

About Pavan Kumar Reddy Itikyala Mulinti

Clinical Research Professional | Central MonitorClinical Research professional with 3 years of experience in managing clinical trials using a risk-based monitoring approach. Skilled in real-time data analysis and central monitoring to identify site performance trends, protocol deviations, and operational risksKey risk indicators review and analysis, Adept at developing mitigation strategies to enhance study compliance, streamline processes, and ensure alignment with protocol and SOP requirements.Core Strengths: Real-time data analytics for proactive issue identification🧩 Risk-based monitoring to optimize site performance and KRI review Mitigation planning to resolve operational challenges Protocol and SOP compliance oversight Cross-functional collaboration for study successKey Responsibilities & Achievements: Study Oversight: Independently managed clinical studies, maintaining timelines, databases, tracking tools, and project plans.🤝 Team Collaboration: Contributed to study team meetings, implemented action items, and supported process improvements and issue resolution. Stakeholder Communication: Acted as primary contact for project deliverables, ensuring clear communication across sites and internal teams. Operational Insight: Conducted trend analysis, monitored protocol compliance, and reviewed clinical alerts to ensure study health.🧪 Site Evaluation: Assessed site practices for protocol adherence and regulatory compliance. eTMF & ICF Management: Oversaw Trial Master File and Informed Consent Form processes, ensuring accurate documentation and audit readiness. Data Analytics & Review: Extracted insights from subject-level data, identified deviations, and performed in-depth data reviews with clinical sites. Documentation & Reporting: Maintained study-specific tools/templates and provided performance updates from global to local levels. eCOA Oversight: Remotely monitored eCOA data for quality, integrity, and protocol compliance. Backup POC & SME Roles: Served as backup Point of Contact and SME for Local Study Team calls, onboarding Central Monitors, and supporting portfolio-level activities.🧩 Remote Data Review (RDR): Led backend RDR coordination, ensuring accurate data uploads and compliance tracking across studies. Quality Control: Performed daily QC checks on i-Site Summary Reports, LST slides, and KRI descriptions to uphold deliverable standards.

Experience

1. Centralized Moniotring Assistant

   IQVIA

   May 2023 — Present · Bengaluru, IN

   As a clinical research professional: I\'ve honored my skills in clinical trials, serving as a bridge between sponsors and CRO and bringing the best of both worlds. My proficiency spans in-depth knowledge of clinical trial operations, eTMF Management, Query Management, SAE reconciliation and a dedicated focus on leveraging the RBQM model for comprehensive clinical data analysis and ensuring the adherence to the GCP and regulatory requirements.Data Management and AnalysisICH - GCP - Pattern Recognition - Data Validation - Data Reconciliation - Query Management -lab and IMP Management -SAE Reconciliation -Patient Safety Monitoring.Risk and Site ManagementRBQM Real Time Data Checking - Regulatory Compliance – Vendor Management, Issue Management - Root Cause Analysis (CAPA)- Remote Monitoring - Key Risk Indicator - Quality Tolerance Limits (QTLs)- Statistical Monitoring Plan.

Education

• Nirmala college of pharmacy kadapa

  Bachelors of pharmacy, Pharmacy

• Rajiv Gandhi University of Health Sciences

  Masters in pharmacy , Pharmaceutics and Drug Design

• Akshara sree intermediate college adoni

  Intermediate, Bipc