Project Manager
Resume:
Thai Doan
*********@*****.*** **** Lyon
Farm Dr
Durham, NC
27713
OBJECTIVE
To seek a challenging career opportunity as a technical support
engineer.
EDUCATION
University of North Carolina at Chapel Hill, Chapel Hill, NC
Bachelor of Science in Biomedical Engineering
December 2001
Bachelor of Science in Computer Engineering
December 2001
EXPERIENCE
Apr 2012 - Dec 2012
Jul 2008 - Dec 2011 ICON Clinical PLC Durham, NC
Senior IVRS Project Manager
> Act as the single point of contact for ICON clients and the
activities that are necessary for carrying out the project
requirements, including deployment requests of hardware and
related software, project updates, project reporting,
development and review
> Lead dedicated support team for ICON's largest IVRS vendor
> Conduct projects in a timely manner in adherence with ICON
SOPs and appropriate regulations and to liaise with other
department managers as necessary to achieve this
> Manage associate project managers from a project perspective
> Assist in the preparation of client proposals as requested
> Form liaisons and established Service Level Agreements
(SLA's) with customers (internal and project related)
> Assist in creating, enforcing and maintaining Customer Care
Center SOPs and internal policies
> Properly document and update issues entered into the issue
tracking tool and ensure the issues are worked to resolution
or closure per the SLA and or CCC processes
> Work on an on-call basis
> Development of a comprehensive project plan that is designed
to establish project milestones and establish communication
processes
> Identify risks and implement contingencies as needed
> Responsible for the financial management of the project and
ensure that the project is delivered on time and within
budget
> Identify scope changes and secure agreement from sponsor for
payment before performing any out of scope work
> Develop and maintain project plans and data management plans,
as appropriate
> Keep individual project costs within budget
> Monitor the quality specification within projects/departments
> Liaise with clients on project related matters
> Liaise with project personnel responsible for carrying out
the project requirements, including forms designers,
associate project managers, maintenance programming, and
quality control personnel
> Ensure all necessary training is provided to staff
> Keep senior management informed of project status in relation
to quality and timelines
> Liaise with other managers to improve the effectiveness of
the organization
> Provide metrics on technology performance
> Provide status reports of all activities, plans, and problems
to management
Dec 2011 - Apr 2012 Worldwide Clinical Trials
Morrisville, NC Local Manager
> Manager over project management, programming, technical lead
and validation group
> Liaise sponsor staff, third party vendors and WCT project
managers to ensure smooth operation of services and rapid
resolution of any problems
> Ensure requests for associated database updates are executed
efficiently and accurately
> Train and supervise IVRS support assistants on study-specific
procedures ensuring that study-specific tasks are completed
and accurately within a timely manner.
> Assist and participate in project-related meetings and
conferences
> Enure that all activities are appropriately documented and
stored in accordance with the relevant SOP and requirements
of the Sponsor company
Jan 2008 - Jul 2008 etrials, Inc. Morrisville,
NC Project Manager
> Overall responsibility for management and direction of the
project team and all aspects of clinical project management,
including timelines and deliverables for IVR, EDC, and ePRO
systems
> Plans and facilitates system development lifecycle activities
necessary to deliver high quality, timely, appropriate
solutions to the client base
> Developing project schedules, project plans, budgets and
forecasting using tools such as Microsoft Project
> Communicating and obtaining approval for resource
requirements with etrials management
> Serve as the primary point of contact to the external client
and to the internal development staff
> Scheduling and conducting weekly project team meetings for
all ongoing projects
> Interact with internal team from various departments in a
matrix environment to ensure quality of service
> Regularly reviewing the ongoing work of the etrials project
team to ensure consistency with client requirements, client
expectations, project budget and timelines
> Identify and execute additional product enhancements/customer
support opportunities with existing clients
> Prepare and manage the User Acceptance Testing process and
assure any deviations or failures are appropriately
documented, corrected and retested as appropriate
> Assist line management in ensuring that all procedures are
executed in accordance with applicable laws, regulations, and
etrials SOPs
> Contribute to product and SOP development in other etrials
departments
> Ensure delivery of validated database to sponsor
> Assist and/or conduct training sessions with sponsor-
designated personnel
> Provide training of clinical study staff at client sites and
investigator meetings
> Participate in sales presentations
Mar 2005 - Jan 2008 PPD Morrisville, NC
Systems Designer
> Gather user requirements and design the technical
specifications for IVR systems and reports for phase II-IV
studies
> Manage and co-ordinate all technical and service aspects of
an IVR technology project used for randomization, supplies
management, and forecasting for clinical trials
> Work with internal and external project teams to ensure the
timely completion of all deliverables
> Manage project timelines and budgets as they apply to system
lifecycle (SLC), Project Validation Testing (PVT), user
testing (UAT) and the 'go live' process
> Act as primary contact with sponsor, including participation
in client meetings and bid support meetings
> Provide input to line managers on a cross functional base to
develop and implement business process improvement
> Develop training materials and system support guidelines and
train users and support staff as needed
> Travel to client sites to attend meetings and conduct user
training sessions
> Participate in the development and revision of standard
operating procedures (SOPs) and best practices
> Assess clinical protocol and other client supplies study
specifications to help design supply chain resolutions
> Forecast and track all clinical supplies to ensure that all
investigator sites are provided with sufficient medication
> Review and release shipments on a daily basis to ensure
timely delivery to investigator sites, including possible
review of shipments for protocols that are experiencing
limited drug supply
> Demonstrated knowledge of GCPs and other guideline
regulations, including international regulations regarding
the conduct of clinical trials
Apr 2003 - Mar 2005 PPD Morrisville, NC
Senior Systems Support Analyst
> Provide direct supervision over associate and mid-level
systems support analysts
> Coordinate weekly team meetings to monitor study progressions
and address issues amongst sub-team
> Provide 24/7 primary end user support for IVR systems via
phone, fax, and email
> Served as the lead support analyst on over 40 protocols
(phases I-IV)
> Served as the primary validation plan/test developer for IVR
systems
> Responsible for monitoring system databases and reporting any
study specific issues to the project team including but not
limited to reviewing drug supply, shipments, inventory,
subject visits and enrollment
> Implemented data load changes as requested by the clinical
team
> Created technical writings for support documentation
directives
> Support a relational database management of study contents
and ad hoc report writing
> Prepare user's guides and personnel PINs for newly activated
sites
> Responsible for conceptual and practical understanding and
execution of issue escalation procedures
Feb 2001 - Oct 2004 Worden Brothers Inc. Durham, NC
Technical Support Engineer
> Addressed 1st and 2nd level helpdesk support via phone, e-
mail, and chat for stock charting program, TCNet, for a user
database of over 1,200,000 end users
> Diagnose and analyze issues with the computer and software
program to provide technical support
> Devised and improved diagnostic processes and documentation
for volume upgrades through Visual Basic
> Solved installation issues on Windows 95, 98, ME, 2000, NT,
XP and Macintosh systems based on software conflicts, memory,
storage space, directory configurations, and user specific
logins
> Diagnosed connectivity issues between networks and servers
based on proxy servers, firewalls, and IP and modem
configurations. Operated within SAP Order Entry System and
CCS Accounts Receivable System
> Assisted customer sales, subscriptions, renewals, and refunds
through training classes and on line applications
> Trained newly hired employees
Apr 2002 - Sep 2002 Nortel RTP, NC
Systems/Quality Assurance Engineer
> Worked on computer migration of Nortel employees from Novell
domain into Win2K
> Managed day-to-day support and networking problems within
Nortel's internal server
> Maintained user files and directories and configured data
into new PCs
> Installed and setup hardware and software on Windows 2000
workstations
> Troubleshoot LAN conflicts associated with wiring and
software clients on network servers
> Overhauled data destructed PCs then configured and quality
tested them for removal from quarantined site
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