SUMMARY

• Highly qualified Project Manager with over ten years’ experience leading people and teams for results while applying hands - on statistical, database and coding skills.
• Proven technical skills and abilities to direct technical and business teams, and coordinate resources to achieve objectives.
• Managed and carried out all phases of the projects lifecycle for information systems solutions, product launches, business developments and business integrations.

• Languages | C++, VB6
• Hands on formulation in SQL Server expressions Oracle 11i software
• Statistical | SAS, Access and Excel analysis and business to business data transfers
• Web Design (Intermediate level HTML, Dreamweaver 7 and ASP)
• Video Editing (Adobe CS3)

PROFESSIONAL EXPERIENCE

Confidential, Deerfield, IL

Technical Project Manager

Responsibilities:

• Managed all efforts related to getting clinical trial websites (IWR RTSM) and backup phone system (IVR RTSM) setup for Phase 1 through Phase 4 clinical trials.
• This included requirements gathering, managing software engineers/validation teams, UAT, implementation and maintenance.
• Responsible for gathering the EDC integration requirements (TIBCO, RAVE, Medidata).
• Lead the turnaround on troubled projects. Tracked project progress via JIRA.
• Develop solutions/efficiencies on live study issues. Actively review Customer Care Operations’ calls on assigned studies.
• Guided global teams and inter-departmental colleagues on study related issues.
• Responsible for delivery of study related documents to client within agreed timelines. Create call flow documentation as necessary.
• Lead user acceptance testing process.
• Manage the complete project amendment process.
• Update specifications and other study related documentation as necessary during maintenance phase of study.
• Responsible for live- study support activities including client contact. Liaise directly with clients on development and/or live study maintenance issues as needed.
• Actively perform Live Project Reviews to identify potential issues and highlight these to relevant internal departments or with the client as needed.
• Communicate with clients as necessary on any aspect of study. Attend investigator meetings as required.
• Provide support and training to new Project Managers and Associate Project Managers.

Confidential, Rosemont, IL

Compliance Project Manager

Responsibilities:

• Responsible for Quality, Regulatory and Research Compliance, Internal Audit, Quality Systems, and business strategy related to regulatory and compliance issues.
• Managed the development and launch of the Company's web-based clinical management solution which physicians use for enrolling, reporting, over reading and ordering of supplies for Confidential arrhythmia monitoring solutions. The website utilizes CSLA .NET version 3.0 framework and SQL server 2005 backend.
• Accomplished business professional possessing an exemplary regulatory affairs and compliance background with a specialization in the medical device manufacturing and healthcare sales industries.
• Advise executives on regulatory strategy and applicable standards; assisted with the development of the 510(k) packages as well as follow-up activities through final clearance.
• Introduced Scrum Project Management Methodology (Agile) to the company.
• Developed, trained, distributed and maintained Confidential ’s Complaint Handling Systems (Visual Basic 6 front-end, SQL 2003 back-end) which was used companywide in order to gather and trend medical devices and service complaints from customers across the US.
• Firsthand experience with the FDA and the Joint Commission audits.
• Constructed the Human Resource’s Disaster Management Plan which abides by Joint Commission and FDA regulations applicable to Confidential Corporation.

Confidential, Chicago, IL

Project Coordinator

Responsibilities:

• Assisted management of projects to ensure goals and objectives were accomplished on time, on budget, to scope, and to customer satisfaction.
• Worked with internal banking clients and project management office to establish deliverables, work flow structures and detailed project plans.
• Worked closely with the business sponsors and management, and personnel from other departments within Confidential as well as vendors to gather project related information and establish project milestones.
• Obtained cost estimates for enhancement projects for Senior Management.
• Wrote project reports and produced documentation according to Confidential ’s project methodology.
• Develop and maintain the project’s work breakdown structure (WBS).
• Setup and maintain SharePoint sites for collaboration and metric reporting.

Confidential, Rosemont, IL

Project Manager

Responsibilities:

• Responsible for tracking client services and reporting profit and loss and revenues.
• Facilitated with project managers to resolve revenue issues or resource discrepancies.

Confidential, Chicago IL

Geographic Information Systems Analyst

Responsibilities:

• Member of the Final Map Production team responsible for quality assurance and the finalization of utility map products for Confidential field employees.
• Used geographic information systems to model electrical utilities solutions.