Lisa Kile's Location
Malvern, Pennsylvania, United States, United States
Lisa Kile's Contact Details
Lisa Kile work email
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Lisa Kile personal email
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Lisa Kile phone numbers
About Lisa Kile
Lisa Kile is a Project Director at PRA Health Sciences at PRA Health Sciences. She possess expertise in clinical trials, gcp, clinical development, cro, clinical research and 32 more skills. Colleagues describe her as "Lisa is an outstanding task drive employee delivering high quality work (across multiple therapeutic areas) consistent with the goals and values of this company. Highly recommend her to anyone."
Lisa Kile's Current Company Details
Lisa Kile Work Experience Details
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Project DirectorPra Health Sciences Jun 2020 - PresentRaleigh, North Carolina, Us
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Director Project ManagementSynteract Sep 2019 - Jun 2020Morrisville, North Carolina, Us -
Senior Project ManagerThe Evanston Group, Inc. Jun 2018 - Oct 2018Shire Pharmaceutical Contract
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Senior Project ManagerWorldwide Clinical Trials Jan 2016 - Jul 2017Research Triangle Park, Nc, Us -
Sr. Clinical Project ManagerInc Research Dec 2013 - Jan 2016Raleigh, North Carolina, Us -
Senior Clinical Project Manager, CnsQuintiles Sep 2012 - Dec 2013Durham, North Carolina, Us -
Project Manager, Clinical Development & OperationsSiemens Healthcare Aug 2010 - Sep 2012Forchheim, DeSiemens Medical Solutions, Molecular Imaging and Biomarker Research -
Global Trial LeaderPfizer Pharmaceuticals Jan 2009 - Aug 2010New York, New York, Us -
Global Clinical Trial ManagerPfizer Pharmaceuticals Jan 2007 - Jan 2009New York, New York, Us
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Clinical Support SpecialistGlaxosmithkline May 2005 - Jan 2007Brentford, Middlesex, Gb -
Clinical Trial ManagerWyeth Pharmaceuticals Apr 2003 - May 2005New York, New York, UsMonitor and assist in the management of Global Medical Affairs-sponsored clinical studies and Investigator Originated Proposal’s (post-marketing studies) in Women’s Healthcare and Vaccines. Assist with selection of clinical investigational sites, contract research organizations, budget negotiations, contracts, and issue resolution.Participate in the development and editing of Phase IV clinical research protocols, CRF’s, informed consents, and final publications.Participate, present, and organize Investigator Meetings and study specific training sessions.Responsible for internal study master file review and ongoing maintenance of approximately 20 GMA sponsored multi-center Phase IV trials and all investigator originated protocols to ensure compliance with internal SOP’s, Regulatory/ ICH - GCP regulations and QA requirements.Perform SAE reconciliation for GMA sponsored trials to ensure consistency between SAEs reported to GSSE and original clinical trial database.
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Lead Clinical Research AssociatePra International Nov 2002 - Apr 2003Raleigh, North Carolina, UsFunction as primary representative for all clinical, site and Clinical Research Associate issues.Assist with investigator recruitment; assist with Investigator Meeting planning and presentations.Create monitoring and Case Report Form guidelines; develop and maintain tracking tools (monitoring visits, protocol deviations, patient enrollment).Create on-site tools (pocket guide, source document worksheets, patient flow sheets).Coordinate CRA site assignments; conduct CRA project training; serve as a resource and back-up for CRAs and sites.Review CRA reports, letters, telephone logs. Assist in preparation for site audits; assist with SAE reporting issues; communicate all project issues to project manager that might affect project budget, timelines and quality.Monitor clinical studies according to Good Clinical Practice, Food and Drug Administration Regulations and International Conference of Harmonization Guidelines.Conduct pre-study, initiation, routine, and closeout monitoring visits; review Case Report Form data as compared to source documentation for accuracy; write detailed site visit reports.Function as a liaison between the site and sponsor; mentor new CRAs.
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Clinical Trial ManagerWyeth Pharmaceuticals Nov 2001 - Oct 2002New York, New York, UsMonitor and assist in the management of Global Medical Affairs-sponsored clinical studies in Women’s Healthcare. Assist with selection of clinical investigational sites, contract research organizations, budget negotiations, contracts, and issue resolution.Participate in the development and editing of Phase IV clinical research protocols, CRF’s, informed consents, and final publications.Maintain investigator master files to ensure compliance with Regulatory and QA requirements.Coordinate communications between key members of the therapeutic team.
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Clinical Research SpecialistEndo Pharmaceuticals Inc Oct 2000 - Nov 2001Serve as full time member of Clinical Research Study Team. Guide study performance according to GCP guidelines and applicable SOPs as a link between the CROs and Endo Pharmaceuticals Inc. Provide study planning input and ensure timely start, conduct, and closeout of ongoing and newly implemented studies. Create and maintain tracking of all regulatory documents received from the CRO’s. Review each site study package to ensure all regulatory documentation meets GCP requirements and for completeness prior to submission to Regulatory Affairs Department. Serve as Clinical Operations representative for the EDMS Implementation Team. Establish document structure, hierarchy, and migration of documents into QUMAS. Participate, present, and organize Investigator Meetings. Support Clinical Operations in the selection of CROs and Investigators. Interface with Clinical Operations and Clinical Development to ensure a comprehensive interface and communication between the two departments. Assist both Medical Writing and the Clinical Operations departments in finalizing, scanning, and book-marking final study reports to compile the eNDA. Responsible for initiating, writing, and finalizing protocol amendments for Phase I, II and III studies.Review and assist Medical Writing and Regulatory with IND annual reports and review of CSR’s.
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Qa AuditorIbah 1998 - 2000
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Crf DesignerPoulenc Rorer Jun 1996 - Oct 1998Responsible for the development of Case Report Forms by implementing core standard modules.The development process includes review of completed CRF’s for accuracy and content.Review of protocols, design of the CRF, coordinate the set up of design meetings with various clinical teams, data managers, coding specialists, statisticians, and working with these teams to finalize the CRF.
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Quality Assurance CoordinatorTektagen Inc Jan 1992 - May 1996Coordinate the company's manual sample handling/control program. Track sample receipt and perform the log in of all samples prior to distribution to the laboratory for analytical and microbiological testing. Expedite sample testing by coordination of relevant documentation with the appropriate samples and by daily update of the master schedule using Microsoft Excel. Interface with laboratory personnel and customers regarding the scheduling of testing and the status of sample test results. Responsible for coordinating stability studies for small molecule and bio-pharmaceutical protein products according to company SOP’s and GMP. Responsible for establishing a Microsoft Access Database for sample tracking and converted the manual system to this computerized system. Track, review, issues and obtains client and technical approval of Protocols, Test Methods, SOP’s, and all related documents. Assist the Director of Quality Assurance with internal quality operations of the company in support of client quality and regulatory requirements.
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Quality Assurance CoordinatorSmithkline Beecham Jan 1991 - Dec 1992Brentford, Middlesex, GbMaintain and improve the biopharmaceutical documentation control system. This includes monitoring and setting priorities for all Validation Protocols, SOP’s, and Specification documents under going revision or approval. Prepare monthly status reports of all documentation in the system. Perform internal auditing of Specification Manuals.
Lisa Kile Skills
Clinical Trials
Gcp
Clinical Development
Cro
Clinical Research
Pharmaceutical Industry
Ich Gcp
Protocol
Regulatory Affairs
Fda
Oncology
Ctms
Clinical Monitoring
Clinical Operations
Vaccines
Regulatory Submissions
Neuroscience
Drug Development
Pharmaceutics
Clinical Study Design
Biopharmaceuticals
Gmp
Validation
Good Clinical Practice
U.s. Food And Drug Administration
Hematology
Cardiology
Pediatrics
Pain Management
Close Attention To Detail
Software Documentation
Pharmacovigilance
Medical Writing
Cro Management
Clinical Trial Management
Documentation
Protocol Development
Lisa Kile Education Details
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Montgomery County Community CollegeGeneral Studies
Frequently Asked Questions about Lisa Kile
What company does Lisa Kile work for?
Lisa Kile works for Pra Health Sciences
What is Lisa Kile's role at the current company?
Lisa Kile's current role is Project Director at PRA Health Sciences.
What is Lisa Kile's email address?
Lisa Kile's email address is ki****@****ast.net
What is Lisa Kile's direct phone number?
Lisa Kile's direct phone number is +161086*****
What schools did Lisa Kile attend?
Lisa Kile attended Montgomery County Community College.
What skills is Lisa Kile known for?
Lisa Kile has skills like Clinical Trials, Gcp, Clinical Development, Cro, Clinical Research, Pharmaceutical Industry, Ich Gcp, Protocol, Regulatory Affairs, Fda, Oncology, Ctms.
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