Prapti Pandharkar
Clinical Documents Specialist (Etmf) at Iqvia @IQVIA
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WORK HISTORY
Clinical Documents Specialist (Etmf) at Iqvia @IQVIA
Pune, IN
Spearheaded initial quality control and classification of over 500 documents monthly into the TMF, ensuring a 100% adherence to established filing processes and TMF specifications.• Conducted comprehensive quality checks on 100+ documents weekly, reducing error rates by 15% and enhancing overall compliance.• Provided actionable feedback to study teams and the eTMF functional lead, resolving quality issues and improving document accuracy by 10%.• Coordinated internal QC reviews that achieved 100% regulatory compliance and maintained inspection readiness.• Verified the inclusion and proper categorization of essential documents, sustaining a 98% accuracy rate during close-out verifications.• Monitored TMFs to assess trends and document completeness, resulting in a 95% quality standard across repositories.• Mentored and trained 5 new team members within the Ringfences Team, accelerating onboarding efficiency by 20%.• Participated in daily allocation processes, contributing to a 30% improvement in document management turnaround.• Collaborated with the France team to review and upload France-specific documents, achieving a 100% on-time submission rate.• Addressed client queries promptly, reducing resolution time by 25% and ensuring high client satisfaction.• Incorporated learnings and recommendations from study teams, driving a 10% improvement in process efficiency.• Contributed to the development of allocation-related procedures, boosting overall productivity by 15%.
ABOUT PRAPTI PANDHARKAR
Experience of working on Multiple Clinical Trial ( Phase 2, Phase 3). Knowledge of…
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