Current Role:A multi-discipline role, with focus on delivering project leadership of assigned complex/multiple projects and line management of assigned personnel, as well as technical oversight in support of Operations deliveries, projects, initiatives, and training development of CDM personnel. Participate in meetings such as recruitment, business development, finance and audits from a CDM perspectivePrevious Experience:Have experience of working on various therapeutic areas including HIV, Oncology, Neurology, Diabetes, COPD, Bronchial Asthma, Cardiology, Ophthalmology, Nephrology, Vaccines, Devices etc.During handling these trials I have been through various scenarios which exposed me to different aspects of Clinical Data Management and helped me to grow as an efficient Data Manager in Clinical Data Management.Experience of working on all phases of trials from Phase I to Phase IV and also on PMS studies including Non Interventional trials as well.Apart from managing CDM projects was responsible to guide the Software Development (SD) team to build Clinical Data Management System (CDMS) – which included creating User Requirement Specification (URS), and helping the SD team to understand the basics of Clinical Data Management and the basic work flows for Data Entry, Data Validation, Query Management flow, different layers of Roles and Responsibilities including the CDM as well as Study Site and Sponsor personnel, Data extraction requirements, Report creation, and Dashboards for getting the study updates real-time.Performed validation of CDMS which included creating and reviewing scripts for Operational Qualification (OQ) and Performance Qualification (PQ), performing PQ with Screenshots and error logs wherever there is failure as per the scripts.Also provided guidance to the SD team for development of Clinical Trial Management System (CTMS) and IVRS modulesHelped team develop SOPs for CDM department in line with 21 CFR Part 11, CDISC and ICH-GCP compliance