Jayshree Jha
Clinical Trial Regulatory Officer @IQVIA
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WORK HISTORY
Clinical Trial Regulatory Officer @IQVIA
EDUCATION
CLINI INDIA
Advance program in Clinical Research and management, Clinical Research
Bombay College of Pharmacy (BCP)
Pharmacy
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Diploma in Business Management
ABOUT JAYSHREE JHA
I have 8+ years of experience in healthcare industry. Currently, performing start up and maintenance activities in assigned studies for investigative sites. Review, track and follow up the progress, approval and execution of documents submitted to RA and EC/IRB -Initial submission package, Informed consent form (ICF), Investigator pack (IP) release document, Investigator Brochure (IB), IMPD, Protocol amendment etc. This role also involves participating in contract negotiation between the site and sponsor where in I act as a Spoc between country specialist, site and sponsor.I have also handled a US based market intelligence client which serves the life-science company and other managed healthcare organization and have experience in Healthcare research, competitive analysis, survey programming, testing, report preparation and preparing market landscape for the the sponsors. Performed comprehensive data management task including data review, writing and clarification. Have experience in Oncology database management, EMR management. This role also involved activities like performing audits and providing feedbacks to medical data analyst on real-time basis that allowed us to provide error free data to the client. Involved in taking corrective action plan (CAPA) with Analyst with recurring errors as and when required.
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