Vijay Vishal Polepalli

WORK HISTORY

EDUCATION

ABOUT VIJAY VISHAL POLEPALLI

Clinical Database Manager & Developer with over 8+ years of specialized experience in Medidata RAVE EDC. I am an expert in Clinical Data Management spanning all phases of clinical trials (Phase I-IV), with a focus on Study Build, Study Conduct, and Study Lock. Proficient as a Medidata RAVE Study Builder and Library Expert, my skills encompass DVS (Data Validation Specifications), CCI (CRF Completion Instructions), CMP (Clinical Monitoring Plan), and DMP (Data Monitoring Plan). I have extensive experience in applying CDISC standards, conducting Lab/SAE Reconciliation, and managing Data Validation and Query Management processes. My expertise includes Data Lock activities such as finalizing data listings, resolving queries, ensuring data consistency, and confirming the integrity of all data points before database closure. I am skilled in developing Custom Functions to enhance data management processes and ensure high-quality outcomes. I also lead User Acceptance Testing (UAT) to validate system functionalities and compliance. Technical proficiency in Python and Selenium allows me to streamline and automate clinical data workflows, improving efficiency and accuracy. My therapeutic area expertise includes Oncology, Cardiovascular, Respiratory, and Psychiatric studies. With a strong commitment to data integrity and regulatory compliance, I deliver reliable and compliant clinical trial data, making significant contributions to successful clinical research projects.