Shraddha Shah Email & Phone Number

With an overall experience of 10+ years in clinical research, I have worked extensively in Clinical Data Management and Regulatory Operations for various global Pharmaceutical companies. Having in-depth knowledge of ICH, GCP, GCDMP guidelines and FDA regulatory requirements, I have extensive experience in all phases of clinical data management from study initiation to database closure.I am currently leading Data Management activities for Phase 1 Gene therapy Trial for Rare Disease. My responsibilities include vendor oversight and managing data, database systems, data visualization tools and documentation from study start up through database lock, within established timelines and with primary goal of ensuring data integrity, optimizing efficiency and providing analysis ready datasets. Managing Project Budget for Data Management activities. Strong focus on TMF documentation and inspection readiness.In my previous role I lead data management activities for Phase 3 Oncology studies. Also, in the past I've successfully led the team to deliver studies in various therapeutic areas like Psychiatry, Respiratory, Cardio-vascular, Neurologic Disorder, Infectious Disease from Phase 1 to Phase 3. I have experience working on Medidata Rave, InForm and Oracle Clinical platforms.As a Team Lead in my previous organization, I specialized in Team Leadership, Project Management and coordination of Complex trial operations across distributed teams in multiple therapeutic areas. I have also been involved with regulatory compliance and audit/inspection readiness of teams and projects.