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Sr. Donor Clinical Project Manager Resume Profile

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VA

SUMMARY: Dedicated, with over 20 years in Research/Healthcare delivery and administration for clinical project management in both public and private entities with experience through the Department of Defense/FDA collaboration as a member of Naval Medical Research Command. I am attentive to detail and possess a history of establishing milestone achievement in Clinical and Public/Environmental Health mandates. I am adept with new technologies and maintain both a professional and didactic background in regulatory translational medicine and other Health IT domains

Professional Certifications/Training

Project Management Professional certification 2011 PMI , MS Project 2010, MS Access PL/SQL with both linear and dimensional models , Sharepoint, Soarian, Sunquest, MS Office Suite, Oracle Forms and Reports, Human Research Subject Protections, Research Ethics, FDA Regulatory Compliance for Good Laboratory Practice, Clinical Practice, Manufacturing Practice, Clinical Research Professional, Certified HIT Fellow for Health Services, EPIC super-user, IBM Websphere, FormsNet, MediTech, Fineos, Visio, MobiLab, Hospira SmartPumps

Areas of Expertise

  • POSSESS EXPERT PMBOK KNOWLEDGE, SKILLS AND ABILITIES USING BOTH WATERFALL AND AGILE METHODOLOGIES
  • ABILITY TO UTILIZE INFORMATION TECHNOLOGY TO SUPPORT ADMINISTRATIVE OPERATIONS DECISIONS
  • SIGNIFICANT EXPERIENCE IN HIGHLY REGULATED CLINICAL RESEARCH ENVIRONMENTS WITH THE DOD AND FDA cGMP, cGLP, cGCP
  • SPECAILIZED EXPERIENCE WITH HEALTH CARE INFORMATION TECHNOLOGY SYSTEMS LEVERAGING BOTH ONSITE AND OFFSHORE RESOURCE REQUIREMENTS
  • POLICIES, PROCEDURES, REGULATIONS IN GENERIC/BIOEQUIVELANCE.
  • ABILITY TO MANAGE CLINICAL AND INFORMATION TECHNOLOGY PROJECTS
  • MHEALTH WITH EXPERIENCE IN MOBILE LABORATORY AND INFUSION PUMPS
  • ABILITY TO EXECUTE AND MANAGE INFORMATION TECHNOLOGY CHANGE MANAGEMENT PROCESSES
  • EVALUATE, DEFINE AND MANAGE PROJECT SCOPE, DELIVERABLES, SCHEDULE, RESOURCE NEEDS AND BUDGET THROUGH SLDC.
  • VENDOR SELECTION AND PROCUREMENT STRATEGIES FOR DISCRETE TASKS/ARTIFACTS
  • RFP AND VENDOR SELECTION EXPERIENCE

Professional Experience

Confidential

Health Project Manager IS applications

Health Information Systems

  • Directed implementation of multiple projects Mobile Laboratory and Smart Infusion Pumps under a mixed matrix environment.
  • Developed plans to stay on budget and schedule by leveraging communication structures between participants, vendors, clinicians and payers.
  • Initiated Steering committee of project owners comprised of Education, clinical, organizational process excellence, and executives to parcel out responsibilities for distinct portions of the overall plan and ensured technical specs, direction and resources were available to deliver these commitments.
  • Created tracking mechanisms for monitoring purposes, Communication strategies, and risk/problem logs.
  • Performed weekly reporting status updates to sponsor/executive committee.
  • work closely with product owner to understand both functional and nonfunctional requirements.
  • Tailored project management and support processes through both legacy administrative mandates and integration into new parent processes as part of the Sentara collection of hospitals.
  • Help resolve interface junctions between information systems, clinical management, and process improvement through sharing an evidenced-based vision of final outcome.

Confidential

Health Modernization Business Project Manager

Business Project Manager Health Modernization. Bloomington, Illinois

  • Manage team of 25 Business Analysts and SMEs both onsite and offshore through Use Case Creation, Scenarios, Requirements, Testing Use case, Process Re-engineering, Procedures, Manuals, Training and Support to include all business process documentation. Experienced in both Waterfall and Agile methodologies.
  • Define and manage project scope, deliverables, schedule, resource needs and budget
  • Serve as the main client interface on projects, clarify strategic requirements, explain complex ideas clearly, and manage expectations
  • Play a dual role of client advocate and internal team advocate
  • Keep projects on track through clear task lists, issue tracking, status reports, and meeting notes
  • Involve team at the optimal levels for project success and overall account utilization
  • Lead efficient meetings and conference calls
  • Clearly communicates project issues and solutions-oriented resolution to the client and internal team
  • Define, initiate, monitor, and manage work order processes pertaining to vendor award selection and deliverable acceptance criteria

Confidential

Health IT Fellow

  • Managed the information technology resources in health care organizations. Possess the knowledge and understanding to be able to discuss the principles of managing health IT from multiple perspectives including clinical, administrative and decision support. Assist organizations to make informed decisions with respect to IT acquisition.
  • Assessed and understood the requirements for specific health information technologies. Clearly define the specific requirements associated with multiple forms of health IT. In addition to system requirement, taking into account the requirements of end users and basic construction of how health IT is stored and used.
  • Linked information technology to improved clinical outcomes and administrative decision making. Helped guide the selection and implementation of health IT with specific attention paid to improving clinical outcomes and improving administrative decisions.
  • Formulated and implemented health information technology policy for the organization. Provided leadership in crafting the policies associated with health IT selection and implementation. Served as a resource for the requirements of government, legal and professional policies using appropriate process re-design/re-engineering techniques.
  • Effectively managed organizational change processes associated with IT implementation. Provided leadership in the organization during adoption of health IT. Familiarity with and know how to effectively implement organizational change with particular attention paid to overcoming resistance and obtaining buy-in from multiple stakeholders. Formulated strategies to help assure health information security. Maintained the ability to develop, plan, implement and interpret policies that help assure the confidentiality and security of health information.
  • Evaluated the multiple electronic health record options currently available and
  • maintained the knowledge, skills, and understanding to be able to identify and discuss ways in which electronic health records are used throughout the organization and how EHR's are used to improve clinical and organizational performance.

Confidential

Sr. Donor Clinical Project Manager/Coordinator

  • Clinical Project Management through provision of Informatics Subject Matter Expertise and Consultation for DOD transplant/medical imperatives via Naval Medical Research Command, HRSA, and the FDA. Initiated, Planned, Executed, Monitored/Controlled, and Closed Clinical Bioinformatic processes/systems in strong matrixed environment primarily using Agile Methodology.
  • Provided direct management of multiple resources to support program initiatives by performance monitoring and resolving technical/project issues. Adopted both Internal Enterprise system and developed methodologies to converse with external clinical health systems. Functioned as liaison between clinical professionals and IT support group while developing and managing milestone schedules.
  • Concurrently ran donations through multiple clinical trial protocols to ensure appropriate donation and subsequent infusion of over 100 people per year.
  • Trained military laboratories, clinics, and other ancillary professionals about case lifecycle requirements for potential donation to include educational component of general trial activities, specific recipient disease models, and translational continuum from research to bedside for successful deliverable. Facilitate negotiation, coordination and engagement with SME's in various disciplines while defining project agenda.
  • Acted as nexus between PI, patient PCP, IT, and donor to resolve or reconcile barriers to success via analytical problem solving techniques. Assisted PIs in contextual workflow design to reconcile clinical desires with IT capabilities wrapped in swath of myriad of regulatory reporting mechanisms like DSMBs, S AE reporting, EHR/CTMS interface, etc to optimize flexibility and configuration while maintaining a disciplined compromise with data normalization.
  • Created milestone charting project to support process improvement and identify interface elements using MS Office products. Collaborated and coordinated between stakeholders in a global integrated worksite environment based on Clinical and Business Decision Support mechanisms.

Confidential

Lab Technician/ Phlebotomist

  • Provided ancillary medical services and laboratory guidance for both inpatient and outpatient populations through both collection and sample analysis.
  • Collected tissue samples for analysis according to JCAHO standards and provided laboratory consultation to floor/unit activity regarding laboratory requirements.
  • EKG performance on inpatients and Health History assessment for triage care needs were defining characteristic of duties. Conducted administrative procedures to order appropriate tests and ensured billing functions were methodically coordinated.

Confidential

Assistant Project Operations Manager

  • Offered remediation and waste expertise to Federal Agencies and Private Companies in both Hazardous and Non-Hazardous domains by facilitating regulated waste profiles and supervisory duties.
  • Directly managed 20 personnel and, depending on the particular project, about 200 indirects.
  • Primary responsibilities involved consulting with client work order requests to provide subsequent staffing, planning, and expectation of deliverables to accomplish this task.
  • Assignmented daily duties and tasks for up to 20 people typically marked this position.
  • Report writing and coordination with government agencies eg DOT, DEQ, EPA .

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