Shweta Kerkar
Clinical Data Management Manager @Amgen
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WORK HISTORY
Clinical Data Management Manager @Amgen
US
EDUCATION
Bombay College of Pharmacy (BCP)
Bachelors of Pharmaceutical sciences, Pharmaceutical
Louisiana State University Health Sciences Center
Master’s Degree, Epidemiology - Master of Public Health (MPH)
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Part time_MBA, Human Resources
Welingkar Institute of Management
Diploma in Business Management
SKILLS
ABOUT SHWETA KERKAR
Masters of Public Health (Epidemiology)- Certified Clinical Data Manger (CCDM) with 6+ years of experience in paper-based & EDC (OC-RDC)Epidemiological Research competencies: • Epidemiological study design, research methods and biostatistical analysis using statistical programming packages such as STATA and SAS. Clinical Data Management (CDM) competencies: • Full range of skills leading and managing end to end CDM processes from study start-up, conduct and close-out for Phase I to clinical trial studies. • CDM Systems: Oracle Clinical 4.5, EDC systems such as OC-RDC and Inform• Therapeutic areas: Cardiovascular, oncology, medical devices and early phase translational science studies. • Project planning and budgeting tasks such as revenue recognition and forecasting on a monthly basis for review by the project manager.Other Roles:• Training & mentoring
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