Ankita Gujar

Support operational planning and execution for clinical development projects Coordinate cross-functional stakeholders across clinical, regulatory, and operational teams Develop and implement SOPs to improve compliance, scalability, and operational efficiency Monitor KPIs, project timelines, risks, milestones, and deliverables (EIC) for effective project governance GxP compliance, regulatory readiness, and documentation management activities Market analysis, business reporting, workflow optimization

Managed healthcare operations and clinical documentation projects in an international environment Onboarding and training for physicians using AI-enabled clinical documentation platforms Supervised virtual medical scribe teams while ensuring productivity and quality Conducted KPI reporting, operational analytics, and performance tracking-Power BI Supported healthcare system optimization, workflow automation, clinical documentation processes Data governance, HIPAA, maintained ~98% operational accuracy

Managed quality documentation and compliance activities for AI-based healthcare solutions Validated physician documentation from Epic EHR systems into structured datasets Conducted quality audits, discrepancy analysis, RCA, and CAPA implementation Supported EHR interoperability and healthcare data integration initiatives Improved documentation accuracy and process efficiency through workflow optimization Supported transition management and knowledge transfer activities

Managed clinical data abstraction and healthcare operations projects for US-based research programs Led cross-functional teams handling EHR-based clinical data curation and quality review Oversaw workload planning, KPI tracking, query management, and operational reporting Coordinated with international stakeholders to ensure timely delivery and quality standards Implemented process improvements to enhance workflow efficiency and data accuracy Monitored operational risks and turnaround times

Curated and standardized oncology EHR datasets for clinical research and real-world evidence studies

Managed oncology clinical data validation, quality assurance, and EDC documentation Performed Query/ discrepancy management, and protocol compliance verification Supported pharmacovigilance activities including AE/ SAE reporting and safety data review Conducted RCA, CAPA implementation, and audit preparation activities Maintained HIPAA compliance and contributed to process improvement initiatives

Extracted and validated healthcare data across multiple EHR and EDC platforms Conducted audits, quality checks, and protocol compliance verification Participated in UAT testing for healthcare quality systems and abstraction tools Developed quality control checklists and audit workflows for operational consistency Coordinated with physician clients and stakeholders for issue resolution and documentation support