Project Manager Supply Chain

Lauren M. Dombrowski

*** ***** ****** *********, ** 19047 ? 305-***-**** ? **********@*****.***

Professional Experience:

ICON Clinical Research - Clinical Trial Associate - North Wales, PA, 06/13

- Present

. Assist Project Manager and Project Director with ongoing conduct of

studies; specifically clinical supply chain management

. Certified and trained to assist Investigational Product (IP)

management for world's largest pharmaceutical

. Coordinate ordering/dispatch and tracking of clinical trial materials

(e.g. lab supplies, drug supplies, CRFs, etc.)

. Attend and contribute to study specific and clinical supply specific

teleconferences and meetings

. Manage clinical data with use of CTMS and applicable internal project

tracking databases

. Ensure quality by utilizing ICH GCP, GMP, SOP's, and all appropriate

regulations

. Set up, organize and maintain study documentation for

internal/external audits

BioClinica - Site Administration Associate, Contract Position - Newtown,

PA, 01/13 - 06/13

. Maintained project-specific clinical site database by populating and

updating project tracking system with demographic information

throughout study

. Distributed site surveys to sites identified by clients

. Sent completed site surveys to Core Lab and/or Technical Imaging

Services for review

. Entered completed site survey data into project tracking system

. Reviewed site surveys for discrepancies or omissions

. Ran exports to populate data from Excel to Microsoft Word site

specific documents

. Ensured sites have appropriate supplies by preparing study kit

materials and binder letters indicating appropriate media as outlined

in protocol

. Secured and prepared media for distribution by signing out and

appropriately labeling inventory

. Responded to requests from sites for media, additional site surveys,

and guidance on trial start-up

. Ensured adherence to project timelines as they relate to the Site

Administration processes by attending project startup meetings and

kickoff meetings as required

Exquisite Homes - Financial Data Manager - Miami, FL, 2/11 - 01/13

. Managed financial data including billing, vendor payments, and

deposits with Quickbooks Pro

. Managed large database of vendor accounts, business contacts, and

agents with Microsoft Excel

. Performed audits on quarterly basis to ensure accuracy using high

attention to detail

Novo Nordisk - Business Support Coordinator, Contract Position - Princeton,

NJ, 11/09 - 2/11

. Uploaded and launched U.S. Clinical documentation to global internet

system for 15+ clinical trials

. Managed over 40,000 online documents following strict FDA audit

deadlines (i.e. 1572's, PI CV's, etc.)

. Served as liaison between Project Associates, Scanning group and Master

Content Administrators by uploading finalized documents from novoDOCs

system to the eTMF (electronic Trial Master File)

. Entered document ID and site numbers in eTMF using strong attention to

detail to ensure accuracy

. Set up and archived TMF and CRF binders; assured quality by following

table of contents, SOPs

Univest - Sales & Service Representative - Newtown, PA,

12/08 - 11/09

. Managed business & personal banking relationships and developed new

business

. Facilitated Investment, Mortgage and Insurance solutions and referred

customer to department

Internships:

ICON Clinical Research, Philadelphia Magazine, Campaign Grid

Education:

University of Massachusetts Amherst 2008 - B.A. in Communications, Minor in Studio

Art

. Dean's List Honors Awarded

. Lorenzo De'Medici School Fall 2007 - Study Abroad Program, Florence,

Italy

University of South Florida 2011- Pre-Masters Speech Language Pathology

program

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