Najmudeen Sulthan

A Clinical Research Professional with more than 8 years of Clinical Research Experience as a Clinical Research Associate,QA Auditor&Project Associate in Saudi Arabia.Have the experience of working in CROs,University environments as well as directly with Sponsors (Pharmaceutical companies). Aspirations to improve human society by means of innovative ideas in public health, healthcare and research. As a Sr.CRA Managed (conducted and coordinated) 35+clinical trials so far including Phase 2-Phase 4 trials&7+ academic based epidemiological research projects. Implementation, monitoring and close-out of clinical trials. Major responsibilities include ensuring the safety and well-being of study participants/patients at assigned sites Ensuring site(s) compliance with study plans and guidelines,Good Clinical Practices and applicable regulations Ensuring data integrity through the source data verification and monitoring process Ensuring site compliance with all Investigational Product storage, inventory, dispensing, dosing, and disposition requirements. As a GCP-Auditor Managed (conducted and coordinated) several GCP Audits so far Involved in several Clinical Trial Data Audits(study documents),Site Audits,Trial Master File Audits,For Cause Audits,Vendor Audits,Database Audits and has experience in USFDA,ICH Guidelines,ISO Standards and local applicable guidelines. As a Project Associate Planning,managing &coordinating clinical research studies Establishes& maintains together with Project team study budget and timelines Serves as the primary project lead for communication &coordination of third-party vendors, escalating issues to Senior Management as appropriate Directs study teams to identify and manage critical path activities such as site Selection,selection and management of vendors, development of risk management plan,CRF& EDC system development, study portal setup, study monitoring, safety reporting, IRB/regulatory submissions &approvals,& study status reporting.