Kriti Khanna Lamba

Part of the Clinical Operations project aimed to transform the current CTMS to IMPACT CTMS Key responsibilities : # Gathering business requirements # Change and Communication management # Stakeholder management # Operations management # Quality Management # Drive internal and third party service review meetings # Owner of the Incident, Request, Change and Escalation processes # Expertise in Business Development # Computer System Validation (CSV)

#Generate & analyse data quality reports from the system, Setup Data Quality Check processes for Clinical Trials based on the SOPs #Propose pro-active monitoring activities # handling non-compliance, support in audits, deviation tracking # Support in process improvement of training records verification for internal and cross-functional teams # Create one-stop solution for reporting of all Process Initiatives, Knowledge Sessions and Synergy instances

Business Outsourcing: Electronic Document Management System for Regulatory Submission Key responsibilities : #Setup of support services for a new Regulatory Document Management System -Define SLAs and KPIs for service delivery #Conduct knowledge transition for offshore team #Incident and Problem Management processes #On-Site coordination - Support in Validation & testing of new requirements, Support in Training Management #Propose monitoring activities to reduce Incident backlog from growing

Business Support Services – Clinical Database Management and Medical Information Collaboration & Medical Management Systems (MIC&MMS). #End user business support for Life Science applications, also test analyst for Global Investigator portal #Incident logging, Analysis, Knowledge Database search and linking, Solution, KB article creation #Expertise in Trial tracking, trial assignments, monitoring site visits, OBI reports, eCRF designing, data validation, labs #Journyx time recording