Ashwini Lolage

Clinical Data Management Executive @Sitec Labs Pvt Ltd

Navi Mumbai, IN

Design and development of electronic Case Report Forms (eCRFs) based on clinical protocols, incorporating edit checks and validation rules to ensure accurate and complete data capture.• Manage end-to-end query resolution processes—generating, tracking, and closing Data Clarification Forms (DCFs)—to ensure data quality and database readiness.• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Medical Writing to support interim analysis and final database lock activities.• Perform data cleaning and discrepancy management to ensure timely, high-quality data deliverables for clinical study reporting and regulatory submissions.• Execute CTMS deployments and validate system performance against User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).• Conduct software validation activities in alignment with Computer System Validation (CSV) guidelines to ensure audit-ready data.• Participate in clinical data review meetings and contribute to strategic data-related decisions across study timelines.