Lila Killensworth has over 20 years of experience in the pharmaceutical industry, including expertise in clinical trial development, contracting, budgeting, and regulatory submissions. She has worked in managerial roles at several large pharmaceutical companies, where her responsibilities included negotiating contracts and budgets with investigative sites, developing regulatory submissions, and managing clinical operations. She has extensive experience in phases 1-4 clinical trials across multiple therapeutic areas.

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Lila Killensworth
919-201-3581
www.linkedin.com/pub/lila-killensworth/6a/65/277
Curriculum Vitae
Motivated results-driven professional with extensive experience and knowledge in the pharmaceutical industry including in depth knowledge of
the clinical trial development cycle. Experienced in developing investigator benchmarking, budgets and contracts, IVRS programming and
regulatory submission publishing.
* Global experience with Phases 1-IV in thefollowing therapy areas: GI, Oncology, Respiratory, Neuro, HIV, Vaccines, ID and CVMet.
* Over 8 years experience in Request for Proposals (RFP) and contracts creation and negotiation with global sites.
* Expert in working on large complex studies, including interpretation of in-depth study designs.
* Developed budget templates and determined fair market value procedure costs through theuse of GrantPlan after thoroughly reading and
interpreting the study protocol.
Work History
Title Contracts Associate
Company/Location PRA Health Sciences, Garner, NC, UNITED STATES
Dates Apr 2016- Present
Responsibilities • Responsible for the commercial relationship with sites involved in clinical trials including work
from contract and amendment language, budget negotiation within the established timeline
parameters. Able to perform in a fast paced environment, create and reset priorities as theneed
arises, identify and raise issues before they become critical, and adjust quickly to thechanges of
a dynamic organization.
• Ensure the successful negotiation and on-going management of clinical trial agreements with
investigative sites.
• Work cross functionally with study team in support of timely site start up for the conduct of clinical
trials including accurate forecast of contract execution timelines.
• Collaborate with the study teamwho will partner with other compliance departments to ensure
country specific laws and regulations are followed to minimize risk in clinical trials.
• Communicate and explain legal/ budgetary issues to internal and external parties per department
guidelines.
• Review and evaluate client requested contract changes and based upon department guidelines
escalates deviations as appropriate.
• In partnership with study management and others as necessary, evaluate priorities and quickly
readjust priorities with thechanging needs of business and theclient.
• Identify and proactively raise issues, as appropriate, prior to their becoming critical or
creates risk.
• Appraisecontracts for completeness and accuracy and ensure adherence to department guidelines;
correct documents and files changes to contracts.
• Participatein client meetings for thepurposeof expediting the contract signing process as directed.
• Create and maintain files for each contract.
• Track all site interaction in contracting database in a timely and accurate manner and ensure
that status updates are fully descriptive.
• Generate ideas and solutions to improve requested contract/budget changes while appropriately
partnering with thestudy team for feedback and execution.
• Enhance skill at discerning and responding to issues at sites that poserisk and escalating
accordingly.
• Advance consistency, timeliness and completeness of all interactions with sitein database.
• Exhibit increasing proficiency in executing documents that are complete and accurate delivered
within shorter timeframes.
• Exhibit proficiency in managing multiple projects and clients with competing priorities.
Title Compliance Manager
Company/Location PAREXEL LTD, RTP, NC, UNITED STATES
Dates Mar 2015- Sep 2015
Responsibilities • Developed and maintained documents, tools, forms and related items in MSWord, Excel, and
PowerPoint, including reformatting and troubleshooting issues with existing documents and macros.
• Provided technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with

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Curriculum Vitae
forms, letters, reports, manuals and other documents.
• Assisted project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of
documentation required for submission to Regulatory Authorities and Ethics Committees
administrative support to thepreparation of contracts.
• In liaison with the CRAs, managed preparation of documents for grant payments.
• Attended budget strategy meetings with project team members.
• Generated investigator grant benchmarks and investigator budgets with high quality and accuracy so
as to assist the study teams with the determination of fair market value.
• Analyzed and translated study protocols to ensurethat every study procedurewas accounted for and
benchmarked in accordance to fair market value.
• Trained in CIA to ensure CIA philosophy was implemented in all benchmark requests and provided
feedback.
Title Analysis Manager
Company/Location GLAXOSMITHKLINE, RTP, NC, UNITED STATES
Dates Jul 2011- Mar 2015
Responsibilities • Developed and maintained documents, tools, forms and related items in MSWord, Excel, and
PowerPoint, including reformatting and troubleshooting issues with existing documents and macros.
• Provided technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with
forms, letters, reports, manuals and other documents.
• Assisted project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of
documentation required for submission to Regulatory Authorities and Ethics Committees
administrative support to thepreparation of contracts.
• In liaison with the CRAs, managed preparation of documents for grant payments.
• Attended budget strategy meetings with project team members.
• Generated investigator grant benchmarks and investigator budgets with high quality and accuracy so
as to assist the study teams with the determination of fair market value.
• Analyzed and translated study protocols to ensurethat every study procedurewas accounted for and
benchmarked in accordance to fair market value.
• Trained in CIA to ensure CIA philosophy was implemented in all benchmark requests and provided
feedback.
Accomplishments • Created test scripts for the very successful Grants Manager workshop I planned and facilitated.
• Expert in working on large complex multiple cohort Oncology studies.
Title Contract Analyst
Company/Location GLAXOSMITHKLINE, RTP, NC, UNITED STATES
Dates May 2007- Jul 2011
Responsibilities ∙ Chosen to be the expert in outsourced early phase (phases I-IIa) Oncology studies working with
ICON. I would meet with the internal study team as well as the ICON study team to agree on the
budget and contract templates.
• Provided subject visit templatesupport to clinical operations group, reviewing benchmarking,
investigator sitecontracts and budgets for new and amended studies.
• Provided subject visit templatesupport to clinical operations group, reviewing benchmarking,
investigator sitecontracts and budgets for new and amended studies.
• Advised study teams on legal language surrounding investigator site contracts.
• Merged approved contract language into each investigator site contract.
• Followed up with investigator sites to ensure contract delivery and receipt of signed protocolin a
timely manner.
• Developed tools that enabled customers to increase efficiencies during thesite contracting process.
• Worked with study teams to create site per patient budgets and investigator contracts.
Accomplishments • Developed tools that eliminated inefficiencies within theinvestigator site contracting process
including maintaining status tracking tool for individual sites for each study.

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Curriculum Vitae
Title RAMOS (IVRS) Coordinator
Company/Location GLAXOSMITHKLINE, RTP, NC, UNITED STATES
Dates Apr 2003- May 2007
Responsibilities • Managed and oversaw the e-CSSO database (electronic clinical supplies shippingorder).
• Proactively met with clinical teams to discuss the e-track SVT, investigator contracts and specs for
the study protocols.
• Monitored theon-going protocols on a routine basis ensuring the studies proceeded smoothly in
terms of drug supply and caller interactions.
• Provided training to GSK depots on the use of the drug supply system.
• Provided Help Desk support, when required.
Title Regulatory Submissions Specialist
Company/Location GLAXOSMITHKLINE, RTP, NC, UNITED STATES
Dates Jul 1996- Apr 2003
Responsibilities • Compiled and assembled INDs, NDAs, supplements and amendments using SWIFT tools
(CoreDossier, CAPRI and Adobe Acrobat) according to FDA guidelines and SOPs.
• Built report structures in CoreDossier for both electronic and paper submissions.
• Assessed and validated the database utilized by Clinical and Regulatory Affairs personnel for
Investigator submissions.
• Reviewed submission documents for adherence to established quality standards and managed
interactions with document suppliers when clarifications and corrections were required using
CAPRI and IMMS.
• Managed all investigator and protocolsubmissions. Prioritized, organized and reviewed all
submission work in a timely manner.
• Authored SOP “Working Practice for the compilation of New and Change in Protocol submissions”.
• Performed submission indexing activities in company database application.
• Submitted new and revised investigator information to the FDA for all active INDs and protocols.
Maintained IND folders for receiving and prioritizing information, prepared the correspondence to
the Agency, compiled thesubmission, and interacted with operational and therapeuticgroups as
appropriate.
• Submitted new and revised protocolsubmissions to the FDA. This entailed preparing the
correspondence to theAgency, compiling the submission package and interacting with Regulatory
Operations staff to ensure an expedited turnaround time.
• Assisted in maintaining department library that contained GlaxoWellcome and other pharmaceutical
product information, publications and reference materials.
• Filed all new FDA submissions in accordance with Document Control Room Procedures.
Education
Graduate, Information Systems Operations Management, May 1996
University of North Carolina at Greensboro, Greensboro, NC, UNITED STATES