Marie Lester Pugh
Associate Director, Clinical Vendor Services at ProTrials Research Inc.- Claim this Profile
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Bio
Credentials
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Virtual Trial Capable
VirTrialNov, 2019- Nov, 2024 -
Association of Clinical Research Professionals (ACRP)
Association of Clinical Research ProfessionalsAug, 2004- Nov, 2024 -
Association of Clinical Research Professionals (ACRP) CRA Certification (CCRA)
Association of Clinical Research ProfessionalsSep, 2004- Nov, 2024
Experience
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ProTrials Research, Inc.
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United States
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Biotechnology
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100 - 200 Employee
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Associate Director, Clinical Vendor Services
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Aug 2018 - Present
Associate Director, Clinical Vendor Services, Oct 2021 to Present Manager, Clinical Vendor Services, Aug 2018 to Sept 2021 Confirm clinical vendor selection criteria, including project(s) scope of work requirements, and implement prior to qualifying and utilizing clinical vendor services Collaborate with QA on clinical vendor performance criteria and ongoing evaluation to verify qualifications and review audit findings Verify that clinical vendor services meet the scoped project needs and the highest standards in compliance with corporate SOPs, project instructions, guidelines, policies and regulatory requirements Create criteria to measure and track clinical vendor performance and related budgets Develop accurate, efficient and value-add tools to track and report key performance metrics and issues Ensure that clinical vendor performance feedback is collected and tracked Liaise cross-functionally to collect and share clinical vendor capabilities and performance Participate with Business Development team in proposals process Build portfolio of clinical vendor service offerings to reference during buds and proposals Maintain communication, develop relationships and build partnerships with vendor contacts Show less
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Site and Resource Manager
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Jun 2011 - Aug 2018
Site and Resource Manager, July 2016 to August 2018CRA Resource Manager, May 2015 to June 2016Clinical Line Manager, June 2011 to April 2015Formulate strategies and action plans to maximize delivery of a high quality monitoring service, ensuring achievement of targets, aligning with company strategiesAllocate resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and trainingManage resourcing for designated customers Maintain systems compliance and oversight for effective project deliveryCollaborate with the CL/PL Drive and manage IQVIA key strategic site relationships in order to build capability, drive productivity and robust quality management in line with site strategy; advocate for these sites internallyManage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is achieved and project targets are metSupport CRAs on solving project specific issues across site portfolioIdentify quality risks and issues and suggest appropriate corrective action plans Manage the quality of assigned resources through regular review and evaluation of work productShare IQVIA and customer key business drivers with all CRA staffDrive decision making in line with these business driversAttend customer meetingsMaximize profitability by ensuring project objectives and customer requirements are achievedEnsure that staff have the proper materials, systems access and training to complete job responsibilitiesParticipate in the selection process for new staff by conducting candidate review and interviewsConduct on-boarding training for new staff Responsibilities include planning, assigning, and directing work; gathering feedback for appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problemsMentor and coach peers Participate in quality and process initiatives Show less
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Senior Clinical Project Manager (Oncology & CNS)
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Mar 2005 - Jun 2011
Senior Clinical Project Manager, Jan 2011 to June 2011Clinical Study Manager, April 2008 to Dec 2010Clinical Team Lead, April 2007 to March 2008Associate Clinical Scientist, Dec 2006 to March 2007Senior Clinical Research Associate, March 2005 to Dec 2006Adhered to ICH/GCP guidelines, federal regulations, applicable SOPsManaged cross-functional project teams to support milestone achievementManaged study issues and obstaclesPlanned and delivered large, complex protocols or global projects in accordance with the scope of work, contracted timelines and study budgetCollaborated with other functional groups within the company Communicated with the sponsor and established a customer service relationship with the sponsor representativeDefined project workloads and assignmentsDeveloped study management plans, team assignments and accountabilitiesOversaw database maintenanceDeveloped project-specific work instructions/procedures and project training for team membersDeveloped quality and risk management plans as well proactive contingency plans to mitigate risk and led problem solving and resolution efforts Established appropriate study tools and processes for the study team to support the execution of project deliverables and study timelinesProvided clinical operations expertise and site monitor leadership Presented project status and performance to management (internally and sponsor)Reviewed and managed project budget, budget consumption and financial reports regularlyReviewed Site Visit Reports (SVRs) Provided input for the development of proposals for new work and project budgetsProvided input to line managers of their project team members’ performance Recommended and supported team members’ further professional developmentMentored and trained other project team members Provided ongoing training and communication for the teamPerformed clinical monitoring Served on department initiatives Show less
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Senior Clinical Research Associate
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May 2002 - Mar 2005
Senior Clinical Research Associate, May 2005 to Dec 2006Clinical Research Associate, May 2002 to April 2005Performed clinical monitoring in compliance with FDA regulations and all related SOPsMonitored site visits including evaluation, initiation, interim and close-out visitsInstructed the investigational site staff in their role and responsibilities and evaluated site performance and compliance in conducting clinical studiesCoordinated collection of information from investigational sites Monitored regulatory status of studies at sitesPerformed Source Data Verification (SDV)Reviewed Case Report Forms (CRFs)Assisted in Data Clarification Form (DCF) resolutionReviewed Adverse Events (AEs) and Serious Adverse Events (SAEs)Performed study drug accountabilityParticipated in investigator meetingsIdentified and contacted potential investigatorsCompleted site visit reports and follow-up letters and was responsible for all communication with sitesMaintained accurate study filesMentored new staff members Show less
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Senior Clinical Trial Assistant
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Oct 2001 - May 2002
Supported senior clinical monitoring team members in the performance of in-house monitoring activitiesAssisted with in-house investigator recruitment and evaluation via study information formsEnsured completion of regulatory documents by sites required for site initiationEntered and tracked documents in project databaseServed as central contact for designated project communications and associated documentationInteracted with site personnel via study helplineSet-up and maintained accurate Central Clinical Study FilesAttended investigator meetingsAttended staff and project team meetings and completed meeting minutes Show less
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Georgia Department of Agriculture
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United States
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Government Relations
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200 - 300 Employee
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Chemical Laboratory Scientist II, Chemical Laboratories Division
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Nov 2000 - Jun 2001
Developed a program for the testing and analysis of groundwater samples for 142 pesticide compounds using five extraction methods and various methods of instrumentation (GC/ECD, GC/NPD, HPLC) Performed tests on various food matrices to ensure the safety of the consumer Coordinated schedule for sample collection, testing, analysis and reporting Revised and created calculation and documentation tools Utilized databases for sample tracking and reporting and standard reference material Followed, created/wrote and revised SOPs Show less
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Triangle Laboratories Inc
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United States
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Chemical Manufacturing
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1 - 100 Employee
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Laboratory Technician III, Analytical Services
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Jun 1999 - Aug 2000
Coordinated schedule for sample testing based on priority level, turn-around-time and production capabilities Performed column chromatographic clean-up procedures for analysis for chlorinated dioxins and furans (PCDD/PCDF) in a wide variety of sample matrices Trained co-workers on specific analytical procedures Coordinated schedule for sample testing based on priority level, turn-around-time and production capabilities Performed column chromatographic clean-up procedures for analysis for chlorinated dioxins and furans (PCDD/PCDF) in a wide variety of sample matrices Trained co-workers on specific analytical procedures
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Education
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1995 - 1999
University of North Carolina at Chapel Hill
Bachelor's of Science, Biology, Biology, General
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