EDMS Consultant
Resume:
Lisa Santiago
********.****.*.@*****.***
Consultant experienced in developing strategies for successful company-wide
implementations of content management technologies, including 21 CFR 11,
GxP compliance, validation and developing training programs. Experienced
Project manager in managing multiple edms deployments. Proven technical
proficiency in providing system support for the Opentext Livelink
application.
EXPERIENCE/ACCOMPLISHMENTS
CooperVision, Pleasanton, CA October 2011 - Present
Clinical Research Coordinator
1. Organizes clinical files based on the appropriate Standard Operating
Procedures (SOPs).
1. Write SOPs as needed pertaining to clinical trial coordination and
documentation
1. Establishes study Trial Master File (TMF) to maintain complete and
accurate records of all Sponsor, site, CRO, IRB/IEC correspondence,
adverse event and regulatory documents pertaining to the study)
1. Act as centralized coordinator for scheduling, planning and running of
studies with clinical sites.
1. Maintains and documents communication with investigator or
investigator representative(s) throughout the clinical trial from
selection of sites through close-out of sites.
1. Sourcing/ordering, shipping tracking and disposal of investigational
product in coordination with domestic and international clinical sites
and regulations
1. Complete and up-to-date, Source Document match database, etc
Paradigm Consulting Services, Fremont, CA January 2008 - October 2011
Consultant-Livelink 9.7.1 Implementation
1. Provided knowledge-based consulting services with Livelink 9.7 and 21
CFR 11 compliance.
1. Manage electronic documents for Clinical, Regulatory and Quality as
well as configure the user interface for document retrieval within the
application.
1. Provide Livelink System configuration, support and administration.
1. Write procedures, policies, validation documentation and training
materials.
Advanced Clinical Services, San Francisco, CA June 2007 November 2007
Consultant/Manager Clinical Documentation Corporate Compliance
. Provided knowledge-based consulting services with Livelink 9.7 and
Hummingbird including application functionality, system
implementation, 21 CFR 11 compliance and training strategies.
. Lead the re-structuring effort to define a process for managing
clinical trial documentation.
. Developed and Documented business processes.
Matrix-Logic Corporation Novato, CA June 2006- May 2007
Project Manager /Consultant
. Manage multiple projects involving the implementation, upgrade and
maintenance of the Hummingbird Content Management System.
. Provide comprehensive knowledge-based management consulting services
including deploying content management and knowledge management
technologies, training of end users and as-needed applications
support.
Novacea - South San Francisco, CA December 2003 - May 2006
Sr. Documentation Specialist /Project Manager
. Project manager for the procurement, implementation and validation of
a company-wide Electronic Content Management System (Livelink).
. Worked with stakeholders to develop and document business and user
requirements.
. Managed Opentext, Verity vendors and external consultants.
. Wrote training material, established training approach and provided
company-wide training to all users including remote end users.
. Wrote and maintained the Configuration Specification.
. Livelink System Administrator permissions, user and group
administration, XML export, generate LiveReports and System reports,
HTML, SQL.
Fast Track Systems, Inc. - San Mateo, CA June 2001 - November 2001
Document Control Manager /Project Manager
. Managed a project to procure and implement a company-wide Electronic
Content Management System to track software development.
. Developed strategies .for deploying content management technologies,
training of end users and system support and maintenance.
Adicom Wireless, Inc. - Pleasanton, CA July 2000 - April 2001
Document Control Manager
. Maintained engineering database in Agile that included Parts Master,
BOMs and AVL.
. Successfully developed and managed a project to track product
configurations and material master information.
Centeon - King of Prussia, Pennsylvania July 1999 - February 2000
Manager of Regulatory Operations
. Successfully implemented a global Electronic Content Management system
(Documentum).
. Member of applications development team that provided developmental
strategies for enterprise-wide content management systems.
XOMA Corporation - Berkeley, California November 1998 - July 1999
Document Control Associate/Manager
. Maintained Electronic Content Management System.
. Project lead for implementation of a paperless document control system
using RDBMS.
. Managed Document Control Staff.
FMI Incorporated - Novato, California January 1996 - November 1998
Document Control Specialist/Manager
. Designed, tested and implemented a relational database application,
using FileMaker Pro to track route controlled documents in a QA
documentation system.
. Implemented a quality systems application for the Industrios/Platinum
MRP application
EDUCATION:
1. BA in Physical Science, with an emphasis in Technical Writing - San
Francisco State University.
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