Responsibilities:1. 1. Provide support to the Global GSK Sponsored and Supported R&D Trials across all therapeutic area.2. Organize study start-up teleconferences with study team, if required3. Assist in study start-up activities and ensure compliance for the Drug Shipment as per GSK SOP’s4. Update and maintain the data with accuracy and integrity within all relevant GSK study systems.5. Supporting GSK Clinical Study team to meet urgent deliverables ensuring inspection readiness6. Assist the study teams in the close out activities to ensure compliance to SOP and effective study closure7. Compilation and generation of Clinical Study Report Modular Appendices (i.e. LOI and SAT)8. Manage and Archive essential documents as per GSK Sponsor TMF SOP.9. Ensure the process KPI defined are met for the study10. Organize and participating in all appropriate meetings with GSK and TCS

Worked Paralelly with Site monitor and acted as a remote central monitor and managing sites acorss globe.Following up with sites for the resolution of study pending metrics for overall study thereby improving health of the study.Work along with the study peers,for maintaining the data accuracy and reviewing the subject level data and site level data for accurate functioning.Following ICH GCP guidelines and following the standard Operating procedures.Risk Based Monitoring.Sound Knowledge what CRA does at the site as workee closely with site monitor.

Promoted to CPC, and worked on different studies accross the globe.Handled TMF activity.Dealing with client calls.Remote monitoring taks.Data Analysis ( Action Items/ PD’s/ Adverse Events)Excel Expertise

Assiting Leads in various activites such as TMF.Attenting Client CallsWorking on Access management part for Site staffs and Internal team members.Generating reports from various Internals and third party vendor systems.Good Knowledge of GCP