Drishanu Dey

Background

About Drishanu Dey

Welcome to my LinkedIn profile! I am deeply entrenched in the dynamic world of clinical research, where every day presents an opportunity to contribute to the advancement of healthcare. With 2+ years of experience in this field, I bring a unique blend of expertise in clinical data management. I've honed my expertise in CDM related activities from Initiation to closeout, advancing healthcare and improving lives one study at a time. Skills highlights- • Ability to understand and comply with ALCOA standard, Good Clinical Practices, Good Documentation Practices and ICH E6(R3) guidelines. • Central file reviews as assigned and documents findings in appropriate system • Previous working experience in eTMF platforms such as Veeva Vault, Wingspan, Montrium and Trail Interactive. • Runs test data for user acceptance testing during start-up and submits for filing. • Generates user acceptance testing data files post testing for filing in the eTMF. • Completes test logs for filing. • Provide clean patient tracker at a set frequency. • Requests access/revoke to the electronic data capture (EDC) environment for CDM users • Solid understanding of clinical trial process. • Good working knowledge of EDC platform- Medidata, RAVE. • Organizes, writes, distributes, and files meeting minutes. • Actively involved with all phases of clinical trials- Start-up, Conduct and Closeout. • Handled DM activities like running listings, performing metrics, pulling reports from Medidata, and PDR related activities. • Perform document QC and indexing within eTMF. • Performs Medidata site creation for CDM stand-alone studies • Participates in patient data report (PDR) quality control review and performs PDR filing • Performs tasks associated with generation of data review utility (DRU) listings • Demonstrated effective communication skills. • Strong organizational skills with excellent attention to detail.