1.Assistance in implementation of Project Plans related to the Clinical Monitoring responsibilities2.Works as a lead monitor for a project, overseeing CRA performance and timeliness for monitoring.3.Actively participation in identification and selection of investigators and site management responsibilities. 4.Serving as the primary contact for the sponsor/clinical sites5.Conducting on-site Monitoring Responsibilities.6.Cleared regulatory audits without major findings.

Site Evaluations, Site Initiations, Site Monitoring and site close out. Site training in ICH-GCP and study protocol. Compiling Dossier for regulatory submissions (DCGI, DGFT) Maintenance and updation of In-house Trial Master files. Communication with sites for completion and collection of essential documents. Assisting sites for supply management of study related supplies. Meeting Ethics Committee submission timelines. Project Tracking and generating metrics reports (Enrolment, CRFs received and transmitted, queries resolved and outstanding). Manage site budget and finance. Tracking site specific payments. Perform site identification, selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and above-average clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Administer protocol, study related and ICH -GCP training to assigned sites. Establish standard lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the study and adherence to applicable regulations.