Yana Dutt-Singkh

Background

About Yana Dutt-Singkh

MD Obstetrician and Gynecologist /Pediatrician- nephrologist and Senior Clinical Research Specialist with total 18 years experience in multi- site clinical trials in different capacities and different therapeutic applications.• Led and designed clinical trials from initiation and start-up to completion for medical device and drug (phase I through IV) for different Investigational products in different settings (Hospitals, Institutions, Industry).• 18 years of global studies experience and clinical trial design (including IVD product). In depth experience of all stages of clinical trials (phases I-IV, post market surveillance) from designing, planning, executing and reviewing and reporting of results.• Comprehensive understanding of International Regulatory Authority requirements and hands on experience of executing multiple IRB submissions (Central, local) revision; IND, IDE, PMA, HUD submissions. Reporting AEs, UADE, and SAE in medical pediatric device/drug product. Provided and expertise in MedDRA/WHO, EDC system and safety data coding system • Experience of direct interactions with FDA, EMEA, EMA, other RAs. Successful 510K, PMA, IDE, IND submissions,resulted in publications and National/ International presentations • Experience of direct interactions with FDA and other regulatory agencies.Developed Risk based Monitoring strategy for clinical trials.• Excellent knowledge of ICH, GCP, GMP, GLP, FDA regulations and Guidelines, ISO and compliance for novel product development • Prepared and managed budget for different multi- and single-center studies. Generated data to support successfully evidence generation studies, novel product value proposition and multiple regulatory submissions • Led Rare Disease, Orphan Drug, Breakthrough therapy designation submissions. Prepared NIH, OOPD grant applications.• Excellent inclusive team collaborator, manager, strongly goal oriented and dedicated. Great complex adaptive leadership skills with high emotional entelligence values. Developed a great work relationship with Project Key Leaders, Sponsors and CROs.Mentored and supervised CRAs and junior associates