We provide IT Staff Augmentation Services!

Administration Executive Manager/president And Ceo - Independent Contractor Resume

SUMMARY:

  • 15+ years in Global Project delivery concentrated in Healthcare and Clinical/Drug Safety applications, infrastructure, compliance, contracts, records management and product development. Responsible for delivery of IT infrastructure and applications projects in support of pharmaceutical and safety and quality databases.
  • 10+ year history of simultaneously overseeing multiple large, complex, software development, system integration, operational and infrastructure projects/programs, workflow productivity improvements, SOP, WP development, contract negotiations, data analysis, investigation and resolution for complex case work and ensuring successful completion of deliverables.
  • 12+ years in retail district management, HR operations manager and sales.
  • Responsible for budget development of projects comprising - Multi-Million Dollar programs. Proficient in managing project scope, schedules, work plans, budget, risks, resources and deliverables.
  • Proactive, goal-focused professional with demonstrated talent at creating, leading and mentoring motivated teams, in drug safety solutions, workflow and IT upgrades, medical coding, litigation and investigation of claims.
  • PM Database Trainer: responsible for providing Supervision and Leadership, Coaching, Guidance, Training and Staff Development to subordinate senior level individual contributors, contractors and consultants.
  • Skilled communicator: the ability to translate business IT goals to management and technical teams by ensuring a clear definition and understanding of all objectives.

PROFESSIONAL EXPERIENCE:

Confidential

Administration Executive Manager/President and CEO - Independent Contractor

Responsibilities:

  • Responsible for assisting and increasing efficiency for the CEO personally, within the organization, with coordination and support between the all business functions.
  • Key lead management role in operations, SOP, WP guidelines, HR, job posting, hiring, workflow productivity for long-term and short-term planning of customer service operational excellence.
  • Outstanding interpersonal skills in communicating with staff, clients, vendors, and external clients in professional manner. Vendor analysis of SLA’s.
  • Consistent primary information resource for the team, maintaining compliance and consistency, and taking corrective action when needed
  • Duties across multiple program areas; sales, events, development, communications, administrative, operations, IT development, travel, expenses, finance, AP/AR, and personal assistant.
Confidential

Project Manager - Independent Contractor

Responsibilities:

  • Responsible for property accountability and property management for trust and estate listings.
  • Developed internal procedures to maintain property accountability in accordance with regulations and procedures.
  • Excellent communication skills. Conducted weekly briefings and provided asset visibility and status reports.
  • Maintained effective and productive working relations with all supported organizations and vendors, vendor analysis.
  • Exceeded standards of customer expectations and satisfaction through effective and sound judgment.
  • Assumed management of property in receivership and stabilized to a point for favorable rapid sales.
  • Vendor selection/management for maintenance, repair and work order bids.
  • Accurately tracked all invoicing and billing revenue cycles.
Confidential

Senior Project Manager

Responsibilities:

  • High level overall project management; oversight of analysis reports, data entry, form tracking and follow up, mailing, Salesforce CRM, document storage and retention, using Agile methodology.
  • Providing daily administrative oversight and coordination, working with Sr. IT Project Manager, Maintained Program Governance documentation, DCP for contracting and change controls.
  • Experienced/Seasoned PM with proven leadership skills and the ability to interface with C-Level executives, provided MS Power Point data analysis sets of quality improvement data, key decision points regarding regulatory guidelines.
  • Excellent organizational and planning skills.
  • Facilitate and coordinate various Director, Stakeholder and Executive meetings.
  • Create agendas, facilitate and produce meetings minutes and capture action items from these meetings.
  • Responsible for project dashboards, facilitating updates and precise outlines for C-level executives and producing final product within established dates and times.
  • Coordinating, creating and distributing MS PowerPoint presentations, quality improvement data and QI projects. Facilitated in Executive management meetings risks and issues documentation and distribution of resolutions to C-level executives.
  • Pursue assigned work to the highest personal ability and integrity.
  • Notify designated leads conflicts and issues, risks, dependencies, overlap, gaps, and any other items that could impact the implementation dates.
  • Produce detailed reports and notifications as appropriate.
  • Learn and understand the business readiness methodology to be able to track the progress of the development and deployment of business processes.
  • Understand the business readiness methodology to ensure all coordinators/leads of each release are aligned in prioritizing and executing the deliverables to support the implementation dates.
Confidential

Senior Analyst, Pharmacy Network

Responsibilities:

  • Managed the Fraud, Waste and Abuse (FWA) Attestation, Contracts/Forms Tracking Database for Confidential Part D CMS compliance, focusing on overall project administration, contract administration, updates, record management, legal/compliance revisions and management.
  • High level overall project management; oversight of analysis reports, data entry, form tracking and follow up, fax blasts, mailing, document storage and retention, using Agile methodology.
  • Providing daily administrative oversight and coordination, working with Pharmacy Network Manager and participating pharmacies, Maintained Program Governance document control procedures and change controls.
  • Managing other Medicare Part D projects to ensure that project issues are addressed and to promote effective relationships among all parties, assisting other team members when requested.
  • Developed, implemented, and monitored FWA Attestations forms, and Compliance approvals; with internal database consultants and participating network pharmacies.
  • Managed large scale projects related to the Medicare Part D, FWA CMS requirements and collaborate with SMEs and business groups to recommend compliance solutions.
  • Provide oversight and direction to IT staff to ensure that delivery commitments and status aligned with tight program delivery milestones.
  • Establish and maintain relationships with participating independent and chain headquarter pharmacies.
  • Manage monthly reporting, tracked and resolved issues, provide project status to stakeholders, and adhered to established internal and external methodologies and standard operating procedures.
  • Supplied project coordination and production support to visual basic programmers.
  • Successfully managed, design and maintained a database table/form for complete, incomplete, unique/compliance, contract, and audit attestation data collection, document tracking system and all related processes.
  • Developed a manual tracking system for 2013 data capture, revising and maintaining data form and accompanying data specifications guidelines, database users guide/job aids, policies and procedures.
  • Development of program materials including agendas, presentations, and handouts for implementation, design and C-level executive meetings.
  • Reviewing/preparing weekly/monthly reports to management to insure accuracy of data reporting/clinical claims errors; MS Access and Oracle database, Excel, PowerPoint presentations.
  • Suggested Audit visit policies and procedures by working with the Confidential management and compliance personnel to insure timely and accurate data collection and resolution of incomplete Medicare Part D FWA Attestation forms and contractual agreements.
  • Working closely with participating pharmacies to ensure that form collection issues are addressed and resolved quickly.
Confidential

Senior Project Manager

Responsibilities:

  • Managed, focusing on contracts, overall project administration and management. High level overall project management; budget and personnel management; oversight of statistical analyses, publications, and FTE utilization.
  • Providing daily administrative oversight and coordination, working with all Coordinating Center staff and participating sites as needed to ensure that project issues are addressed and to promote effective relationships among all parties.
  • Managing all internal business functions including budgeting, accounting, records management, human resources, and maintaining necessary office space and equipment and website development/maintained.
  • Developing, implementing, and monitoring contracts, budgets, SOW, data use agreements, business associate agreements, hospital participation agreements, and IRB approvals; with vendors, consultants and participating sites.
  • Executed several contracts with internal and external vendors planning, coordinating and executing research databases, drafting research focused proposals and business plans, RFP's, ROI, and SOW.
  • Managed large scale projects related to the quality improvement projects, define business requirements and collaborate with SMEs and business groups to recommend solutions.
  • Facilitated in Executive management meetings risks and issues documentation and distribution of resolutions to C-level executives.
  • Developed statements of work used in contract negotiations to secure vendor services.
  • Provide oversight and direction to IT vendors to ensure that delivery commitments and status aligned with program milestones.
  • Establish and maintain relationships with stakeholders including business partners, group affiliates, management, global / regional / local project teams, IT service providers and support teams.
  • Manage scope, schedule and budget, track and resolve issues and risks, provide project status to stakeholders, and adhered to established methodologies and standards.
  • Determined project staffing requirements, allocated staff accordingly, and ensured that projects are staffed. Administered resource demand and assigned resources for all projects/Service requests and confirm budgets for projects and production support.
  • Successfully managed $800,000 to $1,100,000 project FY budgets and came in under budget by $200,000 for 2 consecutive years.
  • Developed and maintained a secure web based registry for level 3 data collection, ePRO patient reported outcome system.
  • Revising and maintaining the MARCQI Quality Collaborative data form and accompanying data specifications manual, database users guide and data dictionary with Adobe.
  • Participating in development of program materials including agendas, presentations, and handouts for MARCQI Quality Collaborative meetings; MS PowerPoint medical executive C-level summaries of all quality improvement data (graphs/charts), and KPI for final input; Cisco, WebEx, Go To Meeting
  • Reviewing/preparing periodic reports to sites to insure accuracy of data reporting; MS Access, Excel, PowerPoint and Project, Oracle and SAS databases.
  • Data auditing for all sites, including determining Audit Site Visit priorities and working with the Data Auditor and individual site personnel to insure timely and accurate data collection and resolution of Audit Site Visit issues;
  • Develop all site recruitment materials, site selection, eligibility and expectations for participating hospitals and physicians
  • Working closely with Site Coordinators and Clinical/Surgeon Champions to ensure that data collection issues are addressed and that site concerns are resolved
  • Providing and/or delegating education, training and QI for Site Coordinators.
  • Working with the Data Management Director on the design and conduct of QI initiatives for evaluating treatments and improving the care of patients

Confidential, Canton, MI

Pharmacovigilance Project/Program Manager

Responsibilities:

  • Provides leadership to develop complex statements of work, including scope, solutions, staffing and budgets.
  • Coordinates and oversees the infrastructure aspects of the project for Clinical Technology and Delivery.
  • Responsibility for managing all of the Estimated Time & Delivery infrastructure components in project, including project schedule, project resources, and issue resolution.
  • Responsible for multiple projects and interdisciplinary teams including Pharmacovigilance, medical writing, biostatistics, clinical programming, data management and clinical QC to ensure on time, high quality deliverables to clients worldwide.
  • Medical Review and Quality Assurance, Continuous Quality Improvement adverse event reports, processes, work flow, team guidance for final reporting to the FDA and Worldwide Regulatory Authority drug safety submissions, contracts, timelines, project budgets, RFQ, ROI, RFP, SOW.
  • MS Project, MS Excel, Oracle databases, SharePoint, WebEx, ARISg, ARGUS, Oracle Clinical, Clintrace.
  • Successfully managed 3 projects with FY budgets ranging from $675K to $3.7 Million.
  • Serve as the Program Manager between MMS Holdings and multiple Large Pharmaceutical companies for regulatory drug safety and IT services using SLDC methodology. Project teams of 5-35 associates per project.
  • Mentored physicians, medical writers, on GCP Best Practices as part of the organizational move to a best practice-base for Worldwide Pharmacovigilance projects.
  • Provide Project Management oversight of all aspects of client facing bid presentations, program scope, schedule, resource, communication, estimating risks and issue, quality/change and overall management.

Confidential, Ann Arbor, MI

Senior Pharmacovigilance Coordinator

Responsibilities:

  • Provided guidance of all aspects of program case processing schedule, to ensure and drive successful high quality deliverables were achieved.
  • Resolved complex case issues to company/sponsors SOPs.
  • Collected and published baseline metrics for measuring success, quality, progress, project cost, and resource requirements. Identified and communicated any significant deviation in cost or schedule to the business management leaders.
  • Mentored PV physicians and IT database developers in PV Best Practices for accurate worldwide drug safety submissions.
  • Process adverse event reports from post-marketing, global product recalls, and clinical studies activities using company SOPs, sponsor requirements, worldwide regulations and guidelines.
  • Co-Lead a team of 25-30 PVC’s and 5 Team Leaders. Back up to the 2 of the project managers.
  • Medical Review and Quality Assurance, Continuous Quality Improvement adverse event reports, processes, work flow, team guidance for final reporting to the FDA. ARISg/ARISj document management and workflow systems. ARGUS and ARGUS Japan safety database system and other homegrown safety databases.
  • IT issues liaison and representative for i3 drug safety dept. interaction with i3 IT executive staff and external clients. Work/resolve IT issues for the department as quickly as possible. Filter questions and problem solve for HQ internally and externally. Used Cisco, WebEx, and GoToMeetings for large teleconferencing.
  • Implement, design and develop processes for continuous work flow improvements and FTE utilization per project.
  • Provide ongoing training and interaction with internal and external clients with QA and CQI and personnel, including medical writing, project management and drug safety management and drug safety team members.
  • Demonstrated commitment to ongoing team improvement with high quality input of medical writing into department database following company SOP’s and worldwide regulatory guidelines. Review and QC/QA adverse event reports.
  • Track and triage of AE reports, including entry into database and writing the MedWatch narrative. Process follow-up adverse event reports, post marketing and clinical Phase I, II, III and IV SAE reports and litigation cases.
  • Perform follow-up queries on adverse event reports.
  • Provide ongoing training and interaction with clients and personnel internally, including medical writing, project management and drug safety management and drug safety team members.

Confidential, Ann Arbor, MI

Drug Safety Associate

Responsibilities:

  • Performed department lead responsibilities for ARISg technical team modification group including project work, issue resolution processes, status reporting queries. Assisted senior IT management in the planning, and implementation of new technical architecture to support case processing and workflow design.
  • Served as member of the ARISg Mod Squad (ARISg enhancement/modification group), testing and validating database systems.
  • Acted as AE coding representative and resource for department.
  • Served as representative for the ARISg User Community for the department in the development, innovation, enhancement, and implementation of many special IT improvement projects, database clean up issues and projects, and process redesign.
  • Acted as a liaison for department and maintained open ongoing communication with other ARISg user groups and their functional affiliated teams internally and externally.
  • Served as member of several groups, including Rapid Response Team, E2B Task Force Team, DSS Consistency and Training Team, MedDRA Working Group and Steering Committee, and Freedom of Information team. Demonstrated commitment to ongoing team improvement with high quality input of medical writing into department database following regulatory guidelines.
  • Served as group leader for WCI process redesign issues with ARISg, Case Flow Technology Application, and follow-up database; trained staff on the above systems and other daily work tools. Provided ongoing training, worked on global product recalls, and mentoring of department colleagues.
  • Processed large, difficult AE case work and performed case review and QA.
  • Accurately summarized and clinically interpreted medical data for staff physicians evaluate and organize serious case data, legal case work, audit reviews, and MS Access database queries.
  • Provided consistently accurate work.
  • Managed unlocking privileges, database and report clean-up. Provided ARISg change request support.
  • Participated in leadership meetings with management staff by providing assistance to the team and department with ongoing improvement projects.
  • Served as member of the ARISg Mod Squad (ARISg enhancement/modification group), testing and validating database systems.
  • Acted as AE coding representative and resource for department.
  • Served as representative for the ARISg User Community for the department in the development, innovation, enhancement, and implementation of many special IT improvement projects, database clean-up issues and projects, and process redesign.
  • Providing ongoing training and mentoring of department colleagues.
  • Provided input for department work practices and SOP revisions.
  • Demonstrated commitment to ongoing team improvement with high quality input of medical writing into department database following regulatory guidelines.
  • Achieved experience with multiple therapeutic, including cardiovascular, endocrine, and CNS.
  • Met all appropriate FDA, worldwide regulatory deadlines.
  • Served on multiple special project teams, including ARISg database clean-up, ARISg 2.4 validation testing, Y2K validation testing, and search projects.

Confidential, Livonia, MI

Front Office Sales, Finance, Warehouse Inventory Specialist

Responsibilities:

  • Sales, AP/AR, customer service for all internal and external customers, order inventory, regulatory compliance
  • Evaluating performance objectives and metrics to determine inbound or outbound productivity requirements to achieve customer time, accuracy, and quality expectations Proactively identifying and leading process improvement initiatives using Lean tools to delight customers
  • Building and delivering productivity plans by reviewing work forecasts, determining productivity requirements, and partnering with other Operations Managers to balance labor
  • Mentoring, training, and developing teammates for career progression, performance improvement, and recognition purposes

Hire Now