• 17 years of experience in the field of Clinical Data Management Programming. 6+ years of people management experience• 7 plus years of experience as an onsite coordinator and Project Manager working closely with the client and managing offshore team.• Rich working experience with Medidata Rave (Architect, Core Configuration, Lab Admin, Translation etc), IxRS, CTMS, dsNavigator, Event Adjudication, Protocol Deviation Management system.• Experience on implementing and managing Clinical Research tools, handling the project schedules, invoices as a Project Manager.• Working as a Business Analyst to identify applications and new recommendations to meet the business requirements.• Working experience on RFIs, RFPs, MSA, SOW documents and negotiating contracts with vendors.• Create Standard Procedures and Work Instructions and conduct trainings for Clinical Research Applications.• Providing Production support for Clinical Applications involving Medidata Rave, IxRS, CTMS and client inbuilt applications.• Vast experience with Medidata Rave in Study design and build (creation for eCRFs, Validations, Amendments/Migrations, TSDV, Creation of Reports, Data extracts).• Experience of working with BOXI, J-Review, SQL to provide ad-hoc and custom reports to business.• Coordinating and managing team as per the priorities, mentoring new hires, handling study Matrix, team forecast and participating in the study initiation meetings. • Good knowledge on ICH-GCP, 21CFR Part 11, writing Standard and Working Instructions in compliance with regulatory guidelines.