Vous êtes sur la page 1sur 3


A client facing project management role, which gives me an opportunity to apply
my analytical, technical, leadership and communication skills.
Authored technical and user requirements to bring label-printing system in-hous
e in accordance with GAMP 4 and 21 CFR Part 11.
Wrote policies, standard operation procedures and supporting forms for internal
business processes and external business partners.
Reviewer of both pre and post execution validation scripts.
Proposed and implemented many procedures for consistent processes and informatio
n flow improvement including departmental process maps.
Developed new hire and ongoing departmental training programs.
Created and implemented Data Control processes to increase proficiency, timely d
eliverables and accurate processes surrounding randomizations.
Assisted in writing standard documentation templates for IVRS Validation Test S
cripts, System Specifications, and Functional Specifications.
Served as liaison between internal and external client in support of new softwar
e development.
United BioSource Corporation October 2009 June 2010
Manager, Project Management Office Clinical Technologies 2009- Present
Responsible for managing a team of project managers and other staff to ensure t
imely release of high-quality software products to our customers.
Work with assigned Project Managers to assess clients business needs in regards
to product and service solution needs.
Help guide process improvement efforts within the Project Management team.
Interact with external clients as necessary to resolve issues and guarantee cli
ent satisfaction throughout product lifecycle.
Serve as an escalation point for issues that cannot be resolved directly by ass
igned project managers by fostering effective and open interdepartmental communi
cation and collaboration.
Communicate client feedback, higher-level client issues and recommendations to
effect change and enhance service and product offerings.
United BioSource Corporation June 2008 October 2009
Project Manager, Clinical Technologies
Interpret clinical protocol and develop IVR/IWR System Requirements Specificati
on Documentation
Serve as primary point of contact during software development, validation and l
aunch of IVR/IWR System
Guide client though user acceptance testing
Provide sponsor and clinical site staff training via face to face and virtual p
Manage project budget and scope
Track study timeline and deliverables
Manage internal study team of developers, testers and project coordinators
Identify and execute product enhancements due to protocol amendments
Present at client demonstration meetings and bid defenses
Bilcare, Inc. August 2006
June 2008
Label Operations Manager
Lead and develop global labeling team
Maintain Label Operations budget
Track and report departmental monthly expenses, revenue, capital requests acros
s 3 global sites
Develop and maintain up to date Process Mapping for department
Prepare Label Operations quotes
Implement and conduct global training program
Maintain and control randomization receipt, storage and distribution
Representation in client audits and investigations
Procure printing supplies and equipment
Audit suppliers
Implement continuous labeling process improvements in the areas of quality, saf
ety, efficiency and productivity.
Review production reports and address deviations with corrective and preventati
ve actions.
Implemented performance measures that meet internal and external customer deman
Ensure the department is compliant with cGMP guidelines by regularly reviewing
new regulatory requirements and directing the update of SOPs.
Bilcare, Inc. February 2006 Aug
ust 2006
Label Coordinator
Assist Project Management team with the labeling requirements for a particular
project by interacting with vendors and business partners.
Ensure label contents are configured appropriately for the specific country, in
tended use, and blinding as necessary.
Work with Project Management and Production to identify labeling operation requ
Work with outside vendors as necessary for procuring printed labels and labelin
Assist other Bilcare sites with procuring labels and labeling.
Communicates with Project Management and Production to established and maintain
project timelines.
Setup study specific labeling requirements in labeling printing software.
Prepare paperwork for Bilcare printed labels and labeling.
Fisher Clinical Services, Inc. September 2005 February 2006
Fisher Automated Clinical Trial System (FACTS) Technical Services, Team Leader
Consults on technical matters of system specifications
Maintain level of quality standards in FACTS systems
Coordinates and approves system change control
Troubleshoot external and internal system errors and issues
Develop training program for Global FACTS Team
Representation in client audits and investigations
Supervise Data Control Coordinators
Prioritize Data Control work to allow for timely and accurate deliverables for
internal clients
Fisher Clinical Services, Inc. March 2004- September 2005
Fisher Automated Clinical Trial System (FACTS) Project Coordinator
Write study specification documentation
Write and execute validation testing of new systems
Prepare client and Fisher report specifications
Design HTML, FAX and IVRS forms client interaction with FACTS
Creation and printing of site materials User Guides, forms, etc.
Manage site and warehouse inventory levels
Communication with sponsors and sites
Fisher Clinical Services, Inc. March 2003-March 200
Senior Label Project Manager
Client and vendor meetings and presentations
Prepare quotes for new projects
Assist with customer visits and audits at FCS
Coordinate Label Project Manager training
Development and implementation of system upgrades
Clinical trial material requirements
Assist management in special projects
Fisher Clinical Services, Inc. April 2002-March 2
Label Project Manager
Assist in establishing pricing structure
Check/Approve database matrices
Purchasing requisitions for supplies and equipment
Randomization Control
Delegation of tasks for label design and printing

Fisher Clinical Services, Inc. July 2001-April

Label Generation Specialist
Protocol breakdown
Prioritize Technicians workload
Participate in new hire training
Maintain printing equipment
Initiate and implement process improvements
Covance Pharmaceutical Packaging Services June 2000-July 2001
Label Generation Technician II
Designing clinical labels
Generation of clinical labels
Set-up database matrices
Development of clinical label processes
Covance Pharmaceutical Packaging Services March 1998-June 2000
Label Generation Technician I
Receiving of incoming labels
Inventory control
Meeting all production and distribution timelines
Recognize and resolve discrepancies with printed labels
Design and creation of label for internal use
Excellent oral and written communication
Ability to prioritize workload for self and others
Work well under pressure
Good at multitasking
Analytical and problem solving skills
Computer skills (MS Outlook, Word, Excel, Access, PowerPoint, Project, Visio and
Technical writing skills
Dependable and self motivated