Naveed Mujawar

Background

About Naveed Mujawar

Clinical Trial Project Management. That's what I do. That's what I keep learning.7 years up and running in Clinical Operations. Primary experience in Sponsor-facing roles and Stakeholder management. Pursuing 'PGP Project Management' from 'University of Massachusetts, Amherst'Performed eTMF, rSDV and CTMS Project Set-up and Execution.Performed eTMF Periodic Quality reviews. Experienced in EDL Preparation and Updation and Monitoring health of Study eTMF until the Close-out phase.Prepared Study eTMF Index, eTMF Plan, Set-up Forms, Periodic Review Documents, Access control Forms, Work Flow Guidance documents, Work Instructions etc.Experienced in eTMF Project Set-up and execution, end-to-end, for UK based Client.Executed Paper to Electronic TMF Migration for India and UK based studies.Served several Sponsor eTMF Projects as Primary Point of Contact.Performed eTMF Document Upload + QC + Periodic Review of TMF.Supported Monitoring teams during Start-up phase - Site Selection, Feasibility, Agreements, EC Submissions, IP Release documentation, Other essential documents tracking.Lead the CTMS and IRT Subject Data Integration process. Authored eTMF SOP, Work Instruction, Training Materials.Acted as a Certified Process Trainer at TCS, Mumbai for 1 year. Used eTMF applications - Veeva Vault eTMF, CARS eTMF, Clinevo eTMF, rSDV and CTMS, ePharmaOne eTMF, PhlexEview.Performed eTMF, CTMS and rSDV System Validation, UAT.Awareness of Validation documents such as IQ, OQ, PQ, RTM, VSR.Managed Vendors for Translation of Regional language documents. Good exposure to QA department activities - Audits, SOP review and approval, CAPA management, Deviation management, Vendor management.