Ivy Coleman Email & Phone Number

Food And Drug Administration (FDA)

Senior level project management support to Center for Drug Evaluation and Research (CDER) Office of Generic Drug Policy (OGDP) division of the Food and Drug Administration (FDA).Provides project management support to PM’s tasked with administrating the Generic Drug Policy Program to include understanding policies and procedures related to processing.

Frederick County, Maryland, United States

Senior level administrator responsible for supporting development and marketing plans for non-profit mental health association.Drafted SOP’s documenting industry and organizational best practices in database management and specialized organizational programs and processes.

Norfolk, Virginia Area/ Baltimore MD

2016-2017: Proposal Manager2012-2016: Team Lead(DETAILED DESCRIPTION OF EACH POSITION IS LISTED INDIVIDUALLY BELOW)

 Senior level associate responsible for supporting corporate business development, capture management, and proposal submission processes. Led strategy sessions on assigned proposals to develop themes and strategic approaches to developing winning proposals. Coordinated internal/external stakeholder communication focused on the development and submission.

Team Lead (contracted To The Centers For Medicare & Medicaid Services)

 Provided strategic research and leadership to the team responsible for implementing Quality Health Plan Certification trainings for the Centers for Medicare and Medicaid Services (CMS) program implementation as mandated by the Affordable Care Act (ACA).  Supported program related stakeholder related communications for the implementation in new health.

 Guided the strategic development and implementation of the Customer Support for Medicare Modernization (CSMM) Helpdesk project training program. Developed both new and revised training materials in alignment with corporate goals.  Conducted new hire orientations and departmental on-boarding training. Performed needs assessment and gap analysis, and.

Baltimore, Maryland Area

 Served as a senior training associate and project task lead for CMS's Office of the Medicare Ombudsman (OMO) team. Led the Ombudsman Needs Analysis Support research task and supported the OMO's Beneficiary Issues Management process.  Provided guidance on data collection and the development of evaluation tools and final reports. Established a.

 Designed and facilitated Employee/Leadership Development and Team Building training sessions for multiple clients. Completed clinical trial project management assignments.

 Provided oversight of a $2M contract that was awarded by the CMS to research, train, and disperse program information to healthcare organizations, seeking to partner with CMS on the implementation of the new Medicare Part D prescription drug benefit.  Identified and managed contract staff and served as a member of the Platform Training Team responsible.

 Directed the development of the clinical operations training department. Analyzed training needs, created training curriculum, and ensured that Standard Operating Procedures, Good Clinical Practice regulatory requirements, and applicable FDA guidelines were met. Designed and coordinated training activities for the clinical development staff. Guided the.

 Member of Clinical Operations Department designated to assist the training manager in the design, planning, implementation and follow-up of training activities. This position required knowledge of Good Clinical Practice, regulatory compliance issues and corporate standard operating procedures.  Developed and conducted training sessions for Clinical.

 Monitored multi-centered clinical trials by interacting with expert physicians, investigators and other study site staff, vendors and CRO's (Clinical Research Organizations), to ensure compliance with Good Clinical Practices (GCP's) for clinical studies for investigational entities filed under FDA (Federal Drug Administration) requirements.