Summary

Top notch Project Coordinator/Junior level PM with extensive experience in the Corporate, Pharma and CRO industries, as well as State level Government, specifically Project Coordination and Change Management including working with the State of NC using Metric Reporting and ED service levels. Strong financial/project P L knowledge. Regulatory Affairs experience including clinical trials and clinical database management systems including CTMS RDMS. Extensive knowledge of training disciplines and content management. SharePoint CTMS Power User.

Core Competencies Include:

• Project Coordination/Junior Level PM Change Management Metric Reporting/P L Knowledge Government Industry Knowledge Regulatory Affairs Background CRO, Pharma and Healthcare Microsoft Project and Office Proficient
• Extensive Training Experience Content Management SharePoint CTMS Power User Manager/Supervisor of Staff

Confidential

Business Analyst

Responsibilities include the analysis and metrics of budget and headcount data for the Corporate Information Security department. Prepare and present on KRI's Key Risk Indicators . In addition, I prepare and present on Corporate Information Security through PowerPoint presentations, on-board all new employees, train new hires and am responsible for strong EA support for Executive Level management including calendar management, travel and expense reimbursements and working within many self-contained BB T software systems.

Confidential

Project Coordinator, Global Logistics

Responsibilities included management of the Global Logistics Project Plan to include 7 main work streams, with some 50 projects across them. Metric reporting from the project plan on weekly Key Productivity Indicator's, Delivery Status on Tasks Past Due and Incomplete Tasks for the Month, RAG status, etc. Also responsible for production of STPs, SLAs, Standards on a Page for governance and measurement and expectations, and Lead and Lag measurements. Weekly meetings with all work stream/lever leads to manage their portion s of the project plan and help them to stay on target. Standardization of all documentation housed on the SharePoint Team Site. Slide presentations and other duties as assigned. Additionally worked on some content management for GSK in-house training.

Confidential

Project Associate II

Major responsibilities include the tracking of various studies through Clinical Trial Management System CTMS and updating subject violations, clarifications and deviations from each protocol as they occur. In addition, I track incoming facsimiles via RightFax from various clinical trial sites across the US, EU and now China and route these as appropriate to include the PI, MMA, CRA, etc. for immediate review and action as needed. I attend 3 weekly meetings and record and distribute the minutes to the appropriate distribution groups.

Confidential

Project Management Coordinator

• I managed the task lists for more than 15 summaries within the overall master project at any given time. I lead meetings on how to deliver and stay on schedule for technical design, testing of interfaces and system architectural deliverable as well as how to best help manage the State Agency's tasks for business requirements, prioritization and completion within their current stage of the process of the GLSuites system before go-live.
• The Business Processes and Automated Systems allowed the many agencies within the State of N.C. to automate many of their daily procedures and processes. The automated process was controlled through a proprietary system GLSuites and was implemented through vendor in Oregon, a management team from the State The BPAS Team and Section Chiefs from the State Division - DHSR. This started as a 9M project with an estimated completion date of Jan 2014, but steadily grew until it was put on indefinite hold in late 2013.
• My responsibilities included assisting the Project Manager on this initiative and helping manage all vendor relations, verifying CSR Implementation Plans and payment of vendor invoices, heading up various Tiger Team Initiatives to define gaps in processes and procedures.
• Produced metric reporting from the project plan on weekly stats including task status, completion status, resource status, etc. Lead weekly meetings with all state section chiefs and outside vendors to manage their portion s of the project plan and help

Change Management Analyst

Confidential

• Tracked CSRs through SharePoint portal for compliance with the findings and approvals, etc. of the weekly ICC Integrated Change Control Team meetings.
• During my position with OMMISS Change Management, I was responsible for the administration of the NCMMIS Program Integrated Change Management Process. I guided and monitored State and vendor activities and commitments associated with the
• submission, approval and implementation of identified system changes within the Medicaid system identifying process gaps determining appropriate courses of action and making recommendations for process improvements and activities which added value to the change approval process. I prepared and presented metrics around business requirements, assessing impact to the development and operations of the NCMMIS Program systems including cost and schedule impacts, developing and recommending plans to monitor and report on the progress of approved changes in formal reports and presentations to project stakeholders. I attended the weekly ICC Integrated Change Control Team Meeting and recorded and distributed the minutes/action items accordingly.
• Managed tracking of in-house CSRs through the many divisions of the State to be represented in the new NCTracks system estimated for go live in October 2013.

Confidential

Project Associate II

• Major responsibilities included the tracking of various studies through CTMS and updating violations, clarifications and deviations from each subject at many of our project sites. Maintained documents in the Trial Master File TMF and the Electronic Trial Master eTMF . I scanned, batched, and indexed clinical documentation tracked incoming facsimiles via RightFax from our various sites in the US, EU and then China which we interacted with directly and routed them as appropriate to the PI, MMA, CRA, etc. for immediate review and appropriate action. This information was extremely time sensitive and was processed immediately, with the patient often in the actual doctor office/medical site thus requiring an immediate response. Recruited and trained new hires Project Associate II . Tested current policies and procedures for the Medical Affairs group resulting in revisions to said policies.
• Helped recruit and train new hires within the Medical Affairs Division.
• Tested and suggested revisions to current training policies and procedures while tracking study information through various spreadsheets and within CTMS I also trained new hires in the use of CTMS .

Confidential

Training Logistics Coordinator

• Project Coordinator for Siebel based Clinical Trial Management System CTMS Release 3. Worked directly for the Project Manager of Training for Quintiles. Tested and posted courses for CTMS through SharePoint. Developed training and logistics materials for worldwide sites, attended kick-off and bi-weekly meetings, recorded and distributed minutes accordingly. Coordinated with each site's Point of Contact and managed training budget for all sites. In addition, I trained additional team staff on the use of CTMS.
• Created training and logistics materials for many of Quintiles' worldwide sites.
• Tested and posted CTMS courses through SharePoint portal while managing training budgets for 20 sites trained team on CTMS.

Confidential

Administrative Coordinator, Regulatory Affairs

• Reported to the Director of Regulatory Affairs, managing clinical documents through an internal Regulatory Data Management System RDMS including Study Protocols, Institutional Review Board documents and Clinical Review Forms which were submitted to the FDA. Created Informed Consent Templates, prepared Regulatory Binders, collected and tracked documentation both paper and electronic, maintained documents in the Trial Master File and the Electronic Trial Master File, as well as the RDMS document repositories. Helped identify risks associated with documentation, processes and systems. I worked closely with cross-functional teams including Clinical Operations, Regulatory Affairs and Medical Writing and spearheaded collaborative efforts through follow up actions items assigned in said team meetings. Provided additional Executive Level support for Director of Regulatory Affairs and a cross-departmental staff of 14. Maintained organizational charts for several departments. Established relationships with outside customers and vendors.
• Created and maintained detailed project tracking spreadsheets and clinical document database for Medical Writing.
• Organization of all logistics and materials for external regulatory consultant meetings.

Confidential

Executive Assistant to CEO

• Organized high level on-site meetings with staff and vendors from multiple locations countries .
• Drafted correspondence on behalf of management.
• Attended weekly meetings with department heads, recording and distributing meeting minutes/action items accordingly.