Clinical Operations:Setup the Research Business UnitProgram Manager with team of 2 Project Leads, 6 Team Leads & 20 coordinatorsManaged over 200 global projects in Drug, Device, Therapeutic, Diagnostic & Regenerative Medicine in multiple therapeutic areasPlanning of budgets & workload managementPreparing Profit & Loss StatementVendor ManagementSetup & Operationalized a Diagnostic Core LabBusiness Development:Strategizing Key affiliations with leading Academic Institutions, CRO’s, Pharmaceutical companies Planning contract negotiations of collaboration with Duke UniversityReviewing, Negotiating & Finalizing Site Contracts/Agreements & Budgets Client & Stake-Holder ManagementScientific & Regulatory Affairs:Scientific Review Board member – reviewing Research Methodology & Study DesignNational Lead & Operations Committee member for Global Clinical TrialsDrug Safety Assessment – review of SAE & causality for the Safety Review Board & submission to the Health Authorities Knowledge in Research Methodology & reviewing Scientific Content of Clinical Trial protocolsQuality Management:Program Manager –Quality Team for Process Development in Clinical ResearchImplemented Quality & Risk Management PracticesSOP ManagementCertified Assessor by Quality Council of India for Clinical Research Accreditation Drove successful completion of 2-Day Mock Training Drill of Health Inspectors Successfully faced multiple inspections by the Health AuthoritiesData Management:Implementation of Data Management processes for Research ProjectsDevelopment of Data Management Plan, Coding DictionariesDesigning Case Report FormsDesigned, Created & Implemented a Clinical Trial Management SystemInitiated Serious Adverse Event Management/Patient Tracking ToolTraining & Education:Mentoring TeamTrained Investigators/RegulatorsTraining on Research Methodology, Publications & Data Management Involved with Continuous Research Education and Training Exercise Program

Clinical Operations:Setup the Research Business UnitProgram Manager with team of 2 Project Leads, 6 Team Leads & 20 coordinatorsManaged over 200 global projects in Drug, Device, Therapeutic, Diagnostic & Regenerative Medicine in multiple therapeutic areasPlanning of budgets & workload managementPreparing Profit & Loss StatementVendor ManagementSetup & Operationalized a Diagnostic Core LabBusiness Development:Strategizing Key affiliations with leading Academic Institutions, CRO’s, Pharmaceutical companies Planning contract negotiations of collaboration with Duke UniversityReviewing, Negotiating & Finalizing Site Contracts/Agreements & Budgets Client & Stake-Holder ManagementScientific & Regulatory Affairs:Scientific Review Board member – reviewing Research Methodology & Study DesignNational Lead & Operations Committee member for Global Clinical TrialsDrug Safety Assessment – review of SAE & causality for the Safety Review Board & submission to the Health Authorities Knowledge in Research Methodology & reviewing Scientific Content of Clinical Trial protocolsQuality Management:Program Manager –Quality Team for Process Development in Clinical ResearchImplemented Quality & Risk Management PracticesSOP ManagementCertified Assessor by Quality Council of India for Clinical Research Accreditation Drove successful completion of 2-Day Mock Training Drill of Health Inspectors Successfully faced multiple inspections by the Health AuthoritiesData Management:Implementation of Data Management processes for Research ProjectsDevelopment of Data Management Plan, Coding DictionariesDesigning Case Report FormsDesigned, Created & Implemented a Clinical Trial Management SystemInitiated Serious Adverse Event Management/Patient Tracking ToolTraining & Education:Mentoring TeamTrained Investigators/RegulatorsTraining on Research Methodology, Publications & Data Management Involved with Continuous Research Education and Training Exercise Program

Assess clinical conditions, collect & analyze data to interpret diagnostic tests, high-risk groups in the field of Invasive, Non-invasive Cardiology & Electrophysiology.Managed Phase III & IV Clinical Trials in Cardiovascular Medicine.Initiated 2 specialty Clinics, a Pacemaker/AICD Device Clinic & a Atrial Fibrillation Clinic – for outcome research, improved treatment & patient counseling.Designed and created several databases for diagnostics & patient care.

Managed Phase III & IV global, multi-centric Trials in Cardiovascular Medicine.Primary focus on Heart Failure & Arrhythmias – especially A. Fibrillation, SVT & heart blocks.Responsible for EECP Lab – Patient care & treatment plan.