1. Introduction

Sayan Chatterjee
B.Sc (H), M.Sc Microbiology, PG Diploma in Clinical Research & Regulatory Affairs, PG Diploma in Patents Law, Certified Clinical Research Coordinator by ISCR, Certification in Pharmaceutical Statistics

2. Research experience

10 years experience in clinical trials, site management, data management, project operations. Experience in various tools like Medidata RAVE, Phase forward Inform, IDM, Redcap, various IVRS and IWRS tools and electronic Trial Master File tool.

3. Research interest

 Currently involved in Phase III/IV multicentric study on childhood acute lymphoblastic leukemia, Study on Gallbladder cancer biomarker discovery study

4. Previous working experience

Cognizant Life Sciences Data Analyst, working for Cognizant on multiple Phase II-IV oncology clinical studies as Data Analyst. My roles included discrepancy management, various external data reconciliation as per protocol and edit check specification, handling and mitigating various external vendor data issues timely manner and performing various data lock activities prior analysis. (August,2016- December, 2017)
Institute of Neurosciences, Research Fellow, As Research Fellow my roles included protocol and CRF designing for Investigator Initiated Neurology studies, Submission of research proposals to IRB at their regular meetings along with various study related documents, Supporting the Investigators in consent procedure and in screening and evaluation of potential study eligible patients. (August,2015-August, 2016)
ICON Clinical Research, Electronic Trial Master File Specialist, My roles included quality check for essential trial documents to ensure they are ready to be included in Sponsor’s trial master file and keeping them audit and inspection ready at all times. (September, 2013- January, 2015)

5. Publication

  1. “Clinical Characterization of Genetically Diagnosed Cases of Spinocerebellar Ataxia Type 12 from India” in Movement Disorders Clinical Practice