1. Lori L. Hall
706 LAKEWINDS TRAIL  ROUGEMONT, NC 27572
MOBILE: (919) 451-8849  WORK: (919) 483-5019
LORI.L.HALL@GSK.COM
LORI.HALL@PAREXEL.COM
SUMMARY OF EXPERIENCE
Diversified background with 32 years expertise, leading large complex global projects, coordinating
and leading activities among numerous functional groups within the company (with an emphasis on
Clinical Operations, Data Management and supporting functions) and ensure that projects are
implemented successfully—on time, within budget, and according to the agreed upon scope.
Experienced in clinical research Phases II-IV, domestic and global. Extensive experience in
Respiratory, Metabolic and Gastroenterology. Other areas of experience include Neurology,
Infectious Disease, and Urology.
CAPABILITIES/SKILLS
 Lead high level, cross-functional teams across international locations
 Manage multiple projects simultaneously
 Identify potential risks and develop mitigation plans
 Effectively communicate with Executive Management
 Ensure tactical implementation plan is in alignment with R&D business goals
 Align program milestones with R&D initiatives
 Manage and direct external resources required for successful project completion
 Manage and direct internal resources required to support project execution
 Strong interpersonal skills; fluent and able to influence others – Dale Carnegie graduate
 In depth knowledge of, and skill in applying, applicable clinical research regulatory
requirements; i.e., Good Clinical Practice (GCP) and International Conference on
Harmonization (ICH) guidelines
 In depth therapeutic and protocol knowledge; i.e., Respiratory, Neurology, Infectious Disease,
Metabolic, Gastroenterology, and Urology
 Excellent organizational and problem solving skills
 Track record of ability to work through others to deliver results to the appropriate quality and
timeline metrics
 Good team leadership skills
 Effective mentoring and training skills
 Excellent customer service skills
 Good judgment
 Excellent presentation skills
 Ability to manage competing priorities
 Strong software and computer skills, including MS Office applications
 Ability to establish and maintain effective working relationships with coworkers, managers and
vendors.

2. Professional Experience
PAREXEL
RTP,NC 27703
Project Leader(transition title) March 2015-present
GlaxoSmithKline Inc. (Former GlaxoWellcome)
Research Triangle Park,NC 27709
Operational Scientific Lead December 2010-March 2015
Serve as Operational Scientific Lead leading multiple, Phase III, global studies.
 Responsible for managing and delivering multiple large PHIII global projects
 Author protocols, clinical study reports and informed consents and other study documents
 Manage cross functional departments to ensure projects are executed and delivered on time and
within agreed budget
 Manage project resource and request additional resource when needed
 Contribute to advisory board meeting prior to Phase III initiation
 Communicate project updates and/or issues to executive management at weekly program
meetings
 Responsible for project budgets - creating, phasing and managing
 Manage protocol feasibility at global and country level
 Responsible for site selection in the United States
 Manage and direct multiple vendors at one time - ePRO, Lab, ECG, Spirometry, etc.
 Vendor selection-Writing RFPs, running Bide Defense meetings, Input into final selection,
review and approve final contracts
 Responsible for development and review of the risk assessment plan
 Train monitors and site staff on protocols and project documents
 Facilitate weekly team and global meetings
 Manage recruitment and develop contingency plans for slow enrollment
 Create innovative tools to simplify procedures
 Write new and revise old SOPs
GlaxoSmithKline Inc. (Former GlaxoWellcome)
Research Triangle Park,NC 27709
Lead Study Management October 2006-December2010
Senior Study Manger August 2004-October 2006
Lead Multiple Phase III global Gastroenterology and Respiratory COPD pivotal studies as a Data
Quality Lead and Operational Scientific Lead
 Ensure quality data is delivery within project timelines
 Coordinate site, monitor and vendor training to ensure adherence to SOPs, GCPs, ICH
 Lead training standards initiative committee for core program vendor
 Provide operations management ensuring data integrity and quality for vendor data-PFT, ECG,
IVR dairy and Pulse Wave Velocity
 Responsible for protocol feasibility and country and site selection
 Ensure high data quality by facilitating regular team meetings to review all data in stream
 Support data standard initiatives and contributing to data decisions on a program level
 Author core documents at study and program level
 Shorten recruitment timelines by 16 weeks leading multiple recruitment initiatives

3.  Lead the first R&D Project team in the implementation of ADP (accelerated delivery program)
 Plan, manage and lead investigator meetings
 Ensure timely study start by managing CRO start up activities
GlaxoSmithKline (Former GlaxoWellcome)
RTP,NC 27709
Sr. Medical Data Scientist September 2001-August 2004
Medical Data Scientist August 1998-September 2001
 Manage Data Management activities for multiple Respiratory, Cardiac and Metabolic studies
 Create study team agreements, CRF completion guidelines, validation manuals, and other data
quality documents
 Manage data cleaning vendor
 Program, validate and maintain clinical trial databases,
 Train personal on EDC
 Deliver data quality databases
 Adhere to SOPs and Regulations
Temporary Tech (GlaxoWellcome)
RTP,NC 27709
Medical Data Associate October 1997-August 1998
Duke University
Durham, NC 27705
Medical Technologist September 1995-October 1997
Durham Internal Medicine
Durham, NC 27712
Medical Technologist July 1988-September1995
Durham Pediatrics
Durham, NC 27705
Medical Technologist August 1985-July 1988
FF Thompson Hospital
Canandaigua, NY 14424
Medical Technologist September 1983-August 1985
Therapeutic Experience
Respiratory, Neurology, Infectious Disease, Metabolic, Gastroenterology, Urology
Initiatives and committees
 Created a new tool for the collection of protocol deviations (PD) enabling countries to enter
PDs into a survey tool (using a URL link) and study team to download data into a single
spreadsheet
 Created a new tool for the collection of Protocol and Study Q&A questions thus decreasing the
number of daily emails for the study team. The questions were collected in a survey tool,
downloaded to a spreadsheet and addressed by the team on a Team Site

4.  Started a Leadership Book Club
 Siebel Local expert responsible for handling local Siebel issues on a daily basis
 DecisionView expert
 Patient Empowered Informed Consent Process work stream-playing a major role in contributing
many tools and processes, creating a global investigator training presentation, an Informed
Consent Role play training presentation and restructuring the Informed Consent Process
database
 Contributed to the writing of Guidance Document SOP WWW 6200 Compliance to FDA
Financial Disclosure rule
 Developed a vendor finance spreadsheet, check list and training slides for simplifying accruals
and study budgets. Presented both during the Study Management Training classes and the
International study managers meeting in Toronto. Held additional budget training sessions for
senior study managers across several therapeutic areas
 Trained study managers on the budget tool using DecisionView in place of the TOT enrollment
graph
 Participated on interview teams interviewing study managers for future positions
 Sat on the Therapeutic Standards Team contributing to the approvals of new therapeutic
standards
 Increased the awareness of informed consent training by facilitating an informed consent role
play and presenting tools
 Lead a team to promote sponsorship and support for the current DecisionView budget tool as
well as find better ways to streamline our study budget process
 Dale Carnegie graduate and graduate assistant
 Active trainer and mentor
Education
Campbell University Buies Creek, NC
Masters of Science Clinical Research 2000-2004
SUNY Fredonia Fredonia, NY
Bachelors of Science Medical Technology 1979-1983
Accreditations
American Medical Technologist (MT AMT) 1987