Sayan Chatterjee

Clinical Data Analyst (SME) at Cognizant

Kolkata, West Bengal, India

Summary
Social work education, Qualitative Research, Public Health and Community Health, Compliance & Documentation Pharmaceutical Research Site Management Clinical Data Management Clinical Development Clinical Trials Life Sciences Hospitals Clinical Research
7+ years of Clinical Research Experience in various roles. Worked as Clinical Research Coordinator (CRC), Clinical Research Trainer, Clinical Data Manager, Clinical Research Associate & Clinical Trial Assistant. Certified in clinical data validation by Accenture Pharmaceutical Services Pvt. Ltd., Bangalore. Currently, working as Pfizer Electronic Trial Master File Document Management Associate II at ICON Clinical Research, India

Specialties: Site Monitoring, Site Initiation and Site Close-out, Preparation of Interim Clinical Study Analysis reports, Training & Mentoring,Clinical Data Validation, Electronic & Paper CRF designing, INFORM Software, Clinical Research, Microbiology, Clinical trial management and site management, Regulatory Affairs and Regulatory Guidelines for conducting clinical trials, Research Methodology, Project management, Basic Pharmacology, Computer Applications, Epidemiology, Organization & Management of Electronic Trial Master File & Paper Trial Master File contents, Quality Checks for the Electronic & Paper Trial Master Files contents, Management of various study supplies for the Investigator Sites, Management of the site-wise EC submission dossier preparation for Clinical Trials & tracking of the site-wise EC submission status, Management & Tracking of the site-wise EC notification for safety letters (CIOMS, SUSARs etc.), Management of the translation requirements for various patient materials (Informed Consent Forms, Patient Cards, Sub-study instruments etc.) & Trial Master File materials, Investigator payments, Training & Mentoring the junior staffs in Document Management using various Pfizer electronic TMF repositories such as PTMF, ELARA etc.,Vendor Management, follow-up with the various site-staffs and study monitors for the retrieval of various site-level and country-level study documents, Drafting Meeting Agendas/Meeting Minutes, Drafting various study-specific correspondences, preparation of the Investigator site feasibility database
Experience

Clinical Data Analyst (SME) at Cognizant

Jul 2016 - Present

Education

MBA at Sikkim Manipal University

Apr 2011 - Jul 2013

Healthcare Services

M.Sc Microbiology at Sathyabama University

Apr 2005 - May 2007

Microbiology

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