David Kosinski Email & Phone Number

Raleigh, North Carolina, Us

• Responsible for managing multiple projects within the designated region, project profitability and revenue, and establishing, growing, and maintaining client relationships. • Oversee multiple IT-related projects related to Pharmacovigilance (PV), Regulatory, CAPA and Veeva. • Develop all project deliverables (e.g., project plan, charter, communication plans, presentations) and conduct reviews/approvals with client leadership, along with contributor to Whitepapers/Blogs for distribution with ProPharma Group Marketing.• Managed a team of 30 Specialists related to a time sensitive medical devices project to ensure >4000 relevant required changes/updates to Global Medical Devices Reports are appropriately reflected before submission to the FDA. • Responsible for on-boarding and off-boarding employees/technicians. • Conduct multi-day per week scrum meetings, along with issue escalation/resolution to ensure smooth and quick deliverables.• Track progress of supplier quality-related remediation activities identified in a GxP IT supplier audit action plan. • Implemented purchasing controls for GxP IT Management along with Regulatory Standard 21 CFR. • Responsible for thorough business analysis ensuring requirements and objectives align with designed technology roadmap.• Responsible for the schedule, quality, and budget of all projects within their designated regions utilizing proficient skills in Workday.• Develop effective sales and marketing proposals while also organizing and conducting professional technical product and services presentations to potential clients. • Provide evaluation of budget compliance, project billing, performance cost and time schedule(s).• Drive project communication (e.g., status reports, dashboards) to all impacted stakeholders.

Lawrence Township, Nj, Us

• Lead project teams to execute large complex initiatives supporting the digital capability (DC) objectives of their Business Unit, while delivering value faster, in an incremental fashion. Collaborate with business leadership and third-party vendors, while managing multiple projects and programs at once.• Experience with Clinical Trial Management System (CTMS), along with strong overall Clinical understanding of Trials, Process, reports, Regulatory and Veeva. • Oversaw planning and execution of Oncology projects in their Business Unit's DC group/functional portfolio to deliver intended outcomes while collaborating on evolving ideas and discovery of new requirements to maximize return on investments.• Managed setup of project management and governance structures in collaboration with IT Business Partner(s) and Digital Capability Managers (DCMs).• Advised and consistently applied Project Management best practices (including Agile, SDLC, PMF, Extensive Excel skills, SharePoint) tools. Continuously improved adoption and maturity of best practices across IT.• Provided support to IT BPs and DCMs, IT Leadership in program operations management of project financials, vendor management and procurement. • Developed and supported implementation of data governance framework along with following regulatory requirements. • Collaborated with ITBPs, DCMs & other Portfolio Managers on business case development for investments, translating PM experience & insights into improved estimates and outcomes.

Northbrook, Illinois, Us

• Managed an average of 25 projects simultaneously at UL for implementations of their cloud-based products for companies in the Pharmaceutical and Medical Device Industries.• Delivered implementations for ComplianceWire, LearnShare, ELMS, SSO/SAML Implementation, Veeva Integration, EDMS Integration. • Implemented the above projects in support of CFR 11 Part 21.• Assisted in the roll out and design of JIRA and Confluence for the Professional Services team. • Project Management responsibilities included: Delivery Management, Project Resource Management, Project Planning, Scheduling, Tracking and Reporting, Risk Management, Client Management and Issue Management.

Lawrence Township, Nj, Us

• Monitored and governed outsourced vendors along with BMS employees.• Created and managed project budget vs. actual expenditures (capital and expense).• Maintained work breakdown structure (WBS) and scheduled project plans along with critical path analysis. • Ensured compliance with required controls for all IT projects, along with supervising project team resources within IT.

Basking Ridge, Nj, Us

• Project Manager for numerous high-profile projects for Verizon Wireless IT Department utilizing Waterfall and Agile methodology.• Negotiate, administer, and manage contracts for all Vendor contracts/communication including Master Service Agreements, Statements of work, purchase orders, for all Enterprise Integration Testing & Solution Organization.• Extensive experience leading numerous Data Center Migrations, Closures, along with opening new ones. • Accomplish financial objectives by forecasting requirements; preparing an annual budget (100+ Million Dollars); scheduling expenditures; analyzing variances; initiating corrective action.• Infrastructure Manager for operation of about 900+ IT assets, including Capacity Management, Lifecycle Management, Migration to Cloud (AWS), Security and Vulnerability Management. • Responsible for setting up of End-to-End Application Performance Management (APM) and Infrastructure on Mission/Business Critical apps, Disaster Recovery, along with standardizing business process framework.• Managed Implementation of Enterprise-wide Application Performance Management Solution on about 60+ Mission/Business critical applications and involved project managing 200+ resources.• Implemented and supported Salesforce Marketing Cloud along with Tableau for numerous application teams within Verizon. • Managed numerous software development life cycle (SDLC) projects at an Enterprise level along with Business Continuity and crisis management.

Basking Ridge, Nj, Us

• Release Coordinator for scheduled Enterprise Release’s for IT, gathering UAT status, Project Information, LOE, Defects and Approach Sign-offs. • Implement “Continuous Delivery” Strategy and roadmap.• Create numerous Executive Dashboards to delivery timely, accurate statistics and information for Enterprise initiatives. • Automated MKS feeds into team’s SharePoint to eliminate manual efforts, along with adding SQL server for historical trending and analysis. • Project Managed the Bedminster Construction Refit program: A 12-Million-dollar effort to increase power capacity to the building, add efficient and sufficient cooling for the data center, and replace all major infrastructures along with the building going “green”.

Basking Ridge, Nj, Us

• Release Coordinator for scheduled Enterprise Release’s for IT, gather UAT status, LOE, Defects and Approach Signoffs. • Implement “Continuous Delivery” Strategy and roadmap.• Automated feeds into SharePoint to eliminate manual efforts, along with adding SQL server for historical trending and analysis. • Project Managed the Bedminster Construction Refit program: A 12-Million-dollar effort to increase power capacity to the building, add efficient and sufficient cooling for the data center, and replace all major infrastructures along with the building going “green”.