Manage GMA-owned Clinical Systems.Act as GMA Representative for Non-GMA-owned Clinical Systems.Analysis and establishment of KPIs and Metrics for Reporting and Dashboard Tools in GMA.Contribute to GMA processes design and reengineering as applicable.

Project Management and Consulting for assigned Projects (Clinical Development, Real World Evidence and Medical Affairs)a) Assigned to Global Medical Affairs - Evidence Generation (Interventional & Non-interventional Studies, Research Collaborations and Investigator Initiated Trials)+ Scientific Review Application System Owner+ Reporting and Data Visualizationb) Project & Resource Management Application SMEc) Mentoring and Guidance of Associate COS & COS

Project Management and Consulting for assigned Projects (Clinical Development, Real World Evidence and Medical Affairs)a) Assigned to Global Medical Affairs - Evidence Generation (Interventional & Non-interventional Studies, Research Collaborations and Investigator Initiated Trials)+ Deep-dive Assessment of Scientific Review Process & Systemb) Assigned to Oncology (Early Development Trials)+ Operational Support to Clinical Trial Leads & Teams: Close-out activities, Vendor Management, Budget Management, Supplies, TMF, Clinical Study Report, etc.c) Assigned to Global Medical Affairs Managed Access Programs+ Operational Support to MAP Leads+ Data Cleaning of MAP Database+ Report & Dashboard design and preparation of MAP Databased) Project & Resource Management Application SME

Site Management for RWE Evidence Generation Projects (Non-interventional Studies)a) Regulatory: Protocol Translation, ICF Customization, EC & HA Regulatory Submissions and Essential Document Packagesb) Contracts & Budgets: Initial and Amendment Contract & Budget negotiationc) Site Management: oversight of recruitment, regulatory, CRF data entry, PRO devices and essential documentsd) Site Monitoring: on-site and remote monitoring visits (from Site Initiation to Close Out)

Project Management Support for assigned Clinical Trials (Phases I to III)+ Support Clinical Systems & Tracking, File Reviews, Vendor Management, Coordinating IP and Supply shipments, Subject Visit Tracking, Project Plans, Audit Readiness, Reporting & Meeting Support.