Managing Principal
CurrentProviding management consulting services within the Pharmaceuticial and Medical Devices domains. Examples of consulting services provided include:• Support client organization’s Clinical, Regulatory, PV, Medical Affairs & Quality portfolios to deliver key priorities and business transformation enablement. • Managed implementation of Oracle Empirica, Argus, Docubridge, IDMP Compliance Management and Medical Insights Publishing (PubStrat) solutions.• Successfully Implemented an Enterprise R&D Data Lake (to ingest Clinical & Operational data from multiple data sources) & CSV lifecycle management solution (to support CSV & Testing processes)• Program Managed efforts to develop a Clinical Integrated Dashboard using Saama LSAC platform to provide a holistic real-time view of CTMS & EDC data across 16 active studies from 25+ CRO sources.• Managed multiple Regulatory & Global Quality initiatives including upgrade of Insight Publishing solution, Veeva RIM/ETMF/CTMS ecosystem upgrades and Veeva-Please Review integration (to enable concurrent authoring).• Led implementation efforts for upgrade of Global Quality Electronic Document Management system (GQEDMS) involving 1000+ users & over 100K documents. Managed a cross-functional team of Business, Technical & Change Management resources to modernize the application and implement a successful cutover of the solution. • Led OCM efforts for implementation of a Veeva Vault Clinical system (intended to replace multiple legacy systems supporting CTMS + ETMF). Key responsibilities included development of comprehensive OCM plan identifying required change preparation activities related to Training, Comms, SOP Updates, Clinical Support SP Site, FAQ/QRC etc., • Led S&T IT rationalization efforts in support of company split of Generics and Brands business and providing the necessary leadership across Clinical, Pharmacovigilance and Regulatory to establish S&T IT landscape transformation in support of a split operating environment