Abhishek Kumar J.
Strategic Business Partner - Dev Global Clinical Operations @Novartis
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WORK HISTORY
Strategic Business Partner - Dev Global Clinical Operations @Novartis
Account Management & Business Partnering for early phase development.Business Case creation for Senior Leadership and CxO reviews, Budgeting, Business stakeholder Management, Vendor Management, Architecture and Security.Lead IT solution analysis as part of RFI/RFPs for the GCO business, translate in to measurable end to end Delivery outcomes. Business Process for Clinical domain, defining technology and solution road-map, financial and technical analysis, leading end to end delivery in close coordination with Global Business, Infrastructure, Architecture and ISC.Configurations Lead for Veeva Clinical Vault Platform implementations, Automation Test Strategy utilizing CSA approach with Validation utilizing Automation tools, leading to Delivery Cycle Time benefit of 30% for Veeva Clinical Vault (eTMF, SSU, CTMS).
EDUCATION
Indian Institute of Management, Lucknow
General Management Program for Executives, Business Administration and Management, General
ABES Engineering College
Engineer's degree, Electronics and Communication Engineering
ABOUT ABHISHEK KUMAR J.
IT Transformation, Digitalization | Pharma R&D Clinical, RA, PV I Account & Portfolio Management Try to apply IT for Competitive Advantage to Business with Aim of Simplified, Automated (processes) and Sustainable (design & manage) solutions.Post Graduate in Management education from IIM Lucknow, India and Bachelors in Technology from ABES, UP Technical University, India.Progressive experience started as Developer (Application dev & Product dev), Data Modeling and Data Management, Business Analyst, Solution Architect, Project/Program Manager, Delivery Lead, Business PartnerDomains (Core)- Pharma drug dev R&D (Clinical, Safety, PV, Quality), Manufacturing.HR, Finance and SCM (O2C, P2P), CRM Solution Discovery, Analysis and Implementation of multiple Platforms:Veeva Vaults (Clinical, Regulatory, Site)ArisGlobal Lifesphere (Safety, Regulatory)Amplexor (Regulatory, Quality)Jobs: Presently IT Director for Business Process/SME-Techno functional for Drug Research and Clinical Trials at Swiss Pharma Major leading end to end Discovery to Deployment of IT solutionsAccount Management, Business Partner for Global Clinical Operations.Demand Planning, Budgeting, Business Case, RFP, POC, Solution Discovery, Delivery Management, E2E, IT DevOps, GxP, Validation, CSA, GAMP CAT-5, 4 and 3.Lead IT system external Audits (FDA, GCC, ANVISA, Health Canada, CAP and NABL, etc for R&D, Plants, CROs, Labs)AI & Analytics enabled Automations.Domain area R&D- CROs/CPUs, Labs, LIMS, Bio-Sample Management, process automations. EDC, CRO, LIMS, ELN, Documentum DMS, Laserfiche, CSC Regulatory Suite, etc.MACR - Developed Industry first EDC/LIS Solution for Global CROs, eCRF design automation over Mobile Devices.ODR - Office of Data Reliability for Ranbaxy Consent Decree for Ranbaxy Plants Remediation program. Defined Industry first Automation Strategy for Delivery during Agile phase, leading to 30% Cycle Time Reduction and Cost Savings with increased measurable Quality for SAAS Platform Implementations.Experience in AI/ML, Cloud, SQL, PL/SQL, UNIX, Testing (TOSCA Automation, ALM, JIRA), Oracle, AWS, ETL, Power BI
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