Ansarul Haque

Background

About Ansarul Haque

A Pharma graduate and Clinical Research professional having 8+ yrs of experience in the domain. Merit of qualifying GPAT/GATE- in 2015 with AIR-1934 and NIPER (National Institute of Pharmaceutical Education and Research)-2015 with AIR-1182. Having current experience in Clinical Data Management at ICON. My responsibilities here are to monitoring the progress of clinical studies at investigator sites and ensuring that studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and ICH-GCP guidelines. My core key responsibilities are to Identify the clinical trial documents and archive it in the correct location within organization database. Perform investigative site file reconciliation requests any new and updated site-related essential and non-essential documents and reviews them for content. Perform QC and verify data; initiate data query resolution and confirm resolution in timely manner and maintain records center security to protect record integrity by ensuring compliance to SOPs. Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines. I have also in-depth knowledge of drugs, its pharmacological action, adverse reaction, and drug monitoring. Knowledge of ICH/GCP guidelines, especially safety and efficacy and different Regulatory Agencies. Gained knowledge of site monitoring like site visit and site visit report, inbound-outbound communication, investigator payments, vendor management and archival of clinical trials documents in to eTMF.