Ashwini Lolage
Clinical Data Management | eTMF Certified | Passionate About Patient Safety & Data Integrity | ICH-GCP | eCRF Design | Query Management | CTMS & EDC Systems | CDM Operations
- Role
- Clinical Data Management Executive at Sitec Labs Pvt Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Ashwini Lolage
I’m a Clinical Data Management Executive with hands-on expertise in eCRF design, CTMS…
Experience
Clinical Data Management Executive
Jan 2025 — Present · 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.
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