Ritika Saun

Clinical Research Professional with experience in eTMF management, clinical documentation, regulatory compliance, quality control, and clinical trial operations. Experienced in maintaining audit-ready study documentation, processing approximately 120 documents/day, achieving a 4-day turnaround time against a 5-day target, and maintaining zero escalations. Knowledge of ICH-GCP, clinical data management, study documentation, investigator support, and cross-functional coordination.

Seeking Clinical Research

Coordinator / Clinical Trial Operations opportunities.

Global Clinical Trial Assistant / Clinical Process Coordinator - IQVIA

(2024-07)

• Manage eTMF documentation and study files in accordance with project requirements, SOPs, and compliance standards, supporting audit readiness.
• Process approximately 120 clinical documents per day while maintaining documentation quality and accuracy.
• Achieve an average 4-day turnaround time against a 5-day target.
• Conduct document QC, indexing, classification, filing, and functional checks within eTMF workflows.
• Maintain zero escalations through proactive communication, issue resolution, and timely follow-up.
• Support clinical project teams by accurately updating and maintaining clinical systems within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to scope of work and SOPs.
• Coordinate with cross-functional teams, sponsors, SGTMs, and C-CRAs to support clinical trial execution and documentation compliance.
• Assist with periodic review of prospective principal investigators and study files for accuracy and completeness.
• Support CRA transition documentation, monitoring-plan compliance checks, EDL correction tasks, and study close-out activities.
• Provide administrative and operational support to clinical project teams during study execution and close-out phases.
• Completed eTMF and Advanced Excel training assessments with 90% score; led team engagement and knowledge-sharing sessions.

Internship - Sun Pharma

Exposure to BA/BE studies and clinical workflows

Internship - Max Healthcare

Patient screening, CRF/ICF documentation, and Phase III oncology trial exposure

Internship - ProcDNA

Data extraction, validation, and healthcare analytics

MSc - Clinical Research - Jamia Hamdard (2024)

Diploma - Clinical Research - St Xavier's (2022)

BSc - Microbiology - PDM University