Cari Brown

***A Stratford Road

Williamsburg, VA 23185

Home: 240-***-**** adimka@r.postjobfree.com

Executive Summary

Experienced Project Manager with strong leadership and relationship-building skills, committed to cost-effective management of resources and quality performance.

Core Qualifications

●10+ years client account management experience

●Excellent communication and presentation skills

●Strong background in people and project management

●Big-picture focus on company goals

●Solid experience managing cross-functional teams

●Staff development

●Budget development, allocation and monitoring

Professional Experience

Home Health Care-Oncology

Nov 2017- Current

Brown Residence – Newport News, VA

●Managed patient care and scheduling of appointments

●Management and administration of Medication per doctor instructions

●Ensured patient completed prescribed therapies and assisted in exercises

●Assisted with daily activities and grooming

Associate Distribution Manager/Study Manager

Jul 2015 to Nov 2017

MedImmune – Gaithersburg, MD

●Forecasting and oversight of phase 1-3 studies in multiple indications.

●Plan and manage DS, DP and IMP distribution, return and reconciliation activities for assigned clinical studies.

●Develop detailed planning and active management of complex distribution scenarios.

●Ensure accurate, on-time delivery of material within local territories and across international borders.

●Develop import/export intelligence and collation of territory specific distribution learnings for Logistics and Clinical Supply

●Contribute to operational effectiveness of Logistics and Clinical Supply.

Distribution Specialist II

Nov 2013 to Jul 2015

MedImmune – Gaithersburg, MD

●Coordinate Distribution of DS, DP and IMP for assigned clinical studies

●Conduct reconciliation of study related DS, DP and IMP

●Work collaboratively within Logistics and Clinical Supply, with external vendors, and with all other interfaces and stakeholders as required to support highly effective clinical product distribution

●Support selection and management of distribution vendors

●Coordinate and document activities related to the production of distribution and returns, and/or accountability and returns documentation, and all other related documentation used by the shipping vendor or clinical site.

Clinical Supplies Specialist II

July 2011 to Nov 2013

MedImmune – Gaithersburg, MD

●Assist with forecasting of clinical needs for study duration

●Create and submit Expiration Date Requests, Label Text Approvals and P&L Plans

●Maintain current, accurate & complete IP study files and file study documents into eTMF

●Assist in maintaining oversight of inventory of all filled-lots & labeled-lots from date of release by Quality Assurance through final reconciliation & closeout of trial

●Review IP shipment requests for accuracy & completeness prior to processing

●Provide updates to timeline & milestone information in relevant tracking tools

●Coordinate & document activities related to label creation (including translations), approval, printing & receipt at vendor

●Coordinate & document activities related to packaging/labeling of IP (i.e. batch record production & review, scheduling production with vendor, etc.)

●Coordinate & document activities related to the production of distribution and returns protocols/summaries, accountability & returns documentation, & other IP-related documentation used by the vendor or clinical site

●Maintain oversight of the returns process (including stock recovery) to aid in documenting full reconciliation of IP

●Coordinate & document activities surrounding complaints, excursions, or deviations received from sites or vendors

Project Manager

February 2007 to July 2011

Fisher BioServices – Rockville, MD

●Forecast study expectations and creating timelines to ensure study kick off and completion are timely Work directly with Finance, Operations, Contracts and IT to ensure project timelines are met and completion of study is accomplished while maintaining total quality

●Develop/amend SOP's and /or business rules for the implementation of new studies and as change requests are made.

●Responsible for daily management of multiple client projects

●Evaluation of projects to determine and secure needed negotiation and interaction with outside vendors to move projects to completion

●Manage and coordinate a client’s project from the signed contract through the collection, receiving, packing and distribution of biological samples, vaccine and Drug Product

●Approved IP shipment requests prior to processing

●Present Timeline and Milestone updates to CRO, QA and Vendors

●Document deviations, excursions and complaints, conduct investigations and assist in close out or CAPA process

● Develop Batch Records/Production Records for Packaging and Labeling Activities

●Monitor CRFs and eCRFs for completeness and legibility consistent with site source documents and protocol adherence

●Maintain study documentation in accordance with FDA regulators and SOP guides

●Create lab manuals, tube tables and requisition forms and train sites for clinical trial participation according to study protocol

●Responsible for full reconciliation of IP, document returns of IP and maintain segregated inventory of returns

Repository Technician

April 2005 to February 2007

Fisher BioServices – Rockville, MD

●Trained employees on new programs and operating procedures

●Maintain inventory of client material

●Quality control of specimens entered into data management system

●Responsible to maintain a vast GMP regulates inventory of hazardous biological specimens at various temperature controlled conditions

●Provide leadership to new technicians as a supervisor in the on-call program

●Provide guidance to Quality Assurance team for the purpose of aiding their understanding of day-to-day processes

Data Entry Technician

November 2003 to April 2005

Fisher BioServices – Rockville, MD

●Perform accurate data entry of biological specimens

●Assure compliance to cGMP requirements and company quality system

●Enter paperwork into appropriate operating systems daily

Education

Montgomery College 2003

Rockville, MD, USA

Thomas nelson Community College 1996

Newport News, VA, USA

Ulster County Community College 1989

Stone Ridge, NY, USA

Keywords

●cGMP and cGLP trained

●CDC and FBI clearance to handle Select Agents

●Trained as a Practical Process Improvement (PPI) team Member and Facilitator to contribute insight for overhead cost savings as part of an onsite PPI team

●Skilled in Microsoft Suite and Project

●Trained as a Lead Investigator for NC’s/CAPA’s

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