Meghana Kapoor

WORK HISTORY

EDUCATION

ABOUT MEGHANA KAPOOR

Accomplished in leading Clinical Data Management Teams, I excel in strategic planning and organizational improvement, demonstrated at VERANEX, NAVITAS LIFE SCIENCES, NOVOTECH and IQVIA. With a knack for cross-functional collaboration and a proven track record in enhancing operational efficiency, my leadership has consistently delivered projects within budget, achieving customer delight and employee development. I am committed to continuous professional development and strive to bring innovative solutions to any challenge I encounter.In-depth knowledge of the processes of clinical data management systems and clinical trial methodology.Good Understanding of ICH GCP.Improvise Organization Operating Procedures and Work Instructions.Worked in multiple projects for all phases – Preclinical, I, II, and IV.Worked in CDMS platforms such as Oracle Clinical Remote Data Capture, Inform, Medidata Rave, Viedoc, Medrio, Inhouse EDCs, etc.Wide therapeutic area knowledge in Oncology, Medical Devices, Cardiovascular, Neurology, Neuropathy, Nephropathy, Women’s Health, Infectious Diseases, Dermatology, Ophthalmology,Autoimmunology, Rare diseases, etc conversant with study design and clinical endpointsStartup: Review of Protocol, eCRF preparation, development of Edit specification, Test case creation for edit checks & validation, User Acceptance Testing (UAT), development of SAS listing specification,preparation of detailed Data Management Plan (DMP), preparation of eCRF Completion Guidelines, creating Data Transfer Specification and Agreement, creating Standard Operating Procedures (SOP),Work Instructions (WI), Site Training, etcConduct: Query Management, Data Trend Analysis, Data review (Query and Listing review), Vendor recon, SAE Recon, Status reports and Study metrics, profile review, Data Stat listing review, guide CRAsand site personnel, Study data listing, presentation to sponsor, etcCloseout: Quality control, eTMF filing, Database lock plan, Database freeze/lock activities, archiving, Audit activities, etcCreating a Budget Plan, Resource plan, Competency Metrics, Track productivity of resources, Actual vs Planned budget reconciliation, Utilization tracking, competency metrics, risk analysis, etc360-degree development of each resource.Actual vs Planned budget reconciliation, Utilization tracking, competency metrics, risk analysis, etcRepresent the organization in Client Audits and qualification audits.Ability to work under pressure and extremely passionate to meetdeadlines / deliverables.