Shweta Kerkar

Clinical Data Management Manager @Amgen

Houston, TX, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2024 — Present

Clinical Data Management Manager @Amgen

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US

EDUCATION

2001 — 2005

Bombay College of Pharmacy (BCP)

Bachelors of Pharmaceutical sciences, Pharmaceutical

2014 — 2016

Louisiana State University Health Sciences Center

Master’s Degree, Epidemiology - Master of Public Health (MPH)

2008 — 2011

SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

Part time_MBA, Human Resources

2007 — 2008

Welingkar Institute of Management

Diploma in Business Management

SKILLS

Clinical TrialsPublic HealthBiostatisticsEdcInformElectronic Data Capture (Edc)Crf DesignIch-GcpSas ProgrammingGeodaGcpOncologyOc RdcCROValidationData ValidationEpidemiologyClinical Data ManagementOracle Clinical21 Cfr Part 11MeddraStatistical Data AnalysisPharmaceutical IndustryData ManagementArcgis

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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Shweta Kerkar — Clinical Data Management Manager at Amgen in Houston, TX, US | Unifers