Meghan Burke

Meghan Burke

Biotech Vendor Project Manager @ ICON plc

About

Results driven IxRT/EDC Senior Project Manager who significantly increases productivity and effectiveness, delivers quality results within budget and on-time, while exceeding customer requirements.

Country

united states

City

chicago

Industry

pharmaceuticals

Skill

project management, quality assurance, software documentation, user acceptance testing, process improvement, business analysis, integration, relational databases, linux, vendor management, clinical trials, training, call flow design, ibm iseries, requirements gathering, telecommunications, data management, cro, edc, sop, pharmaceutical industry, regression testing, test planning, load testing, business process improvement, manage client expectations, unix, xml, auditing, operating systems, change management, mentoring, cross functional team leadership, long term customer relationships, customer satisfaction, product demonstration, leadership, epro, client services, visio, access, sdlc, microsoft sql server, unit testing, ich gcp, ctms, sow, basecamp, rtsm, rave

Experience

vail systems

business analyst and associate project manager

vail systems

2009-2 - 2013-11 · 4 yrs 10 mos
takeda pharmaceuticals

pharmaceutical compliance analyst

takeda pharmaceuticals

2008-2 - 2008-11 · 10 mos

Oversee the Practitioner Validation maintenance process by obtaining and coordinating all necessary information to secure Valid State licenses for over 10,000 healthcare providers. Ensured regulatory compliance for 2000 sales representatives to Prescription Drug Marketing Act (PDMA) guidelines by investigating and resolving disputes, and identifying high risk infractions. Investigated and resolved 500 Signature Audit requests and reported any risk findings to compliance management for progressive action before deadline. Managed the performance management system program and provided quantitative feedback to sales and field leadership identifying root cause point infractions and recommendations for compliance improvement. Contributed to the development of improved reporting tools and compliance systems by evaluating existing processes, providing recommendations, and developing test scripts for implementation.

abbott

pharmaceutical logistics support analyst

abbott

2005-10 - 2006-11 · 1 yr 2 mos

Lead the Field Sales automation strategy focusing on tools and technologies to drive productivity for 14+ sales teams across both manufacturing and distribution divisions. Learned, evaluated, and improved sample order processes by standardizing, documenting and communicating new procedures to field sales personnel. Successfully implemented sample program 3 weeks before deadline to 300+ sales reps. Received 3 awards within 5 months for project dedication and excellent sales support.

cardinal health

medical products customer support

cardinal health

2005-1 - 2006-1 · 1 yr 1 mo
everywarehouse

implementation project manager and sales specialist

everywarehouse

2006-11 - 2008-2 · 1 yr 4 mos

Project manager/sales specialist with responsibilities that included customer demonstrations/training and support, development of customer requirements, Statement of Work, and project and test plans. Developed the detailed business requirements and training documentation for eWMS’s largest pharmaceutical customer and delivered the Statement Of Work before deadline. Conducted customer training and eased change management of customer staff. Wrote/executed test scripts for new application that uncovered critical issues. Collaborated with IT group for resolution to meet scheduled implementation timeframe. Built a documentation portfolio of tailored customer offerings for sales and customer reference.

parexel

associate project manager

parexel

2013-12 - 2015-12 · 2 yrs 1 mo
medavante-prophase

senior project manager

medavante-prophase

2018-12 - Present · 7 yrs 10 mos
eclinical solutions

senior project manager

eclinical solutions

2017-9 - 2018-11 · 1 yr 3 mos
endpoint clinical

project manager

endpoint clinical

2016-1 - 2017-9 · 1 yr 9 mos

Having team members with up to 20 years of industry experience, endpoint provides interactive response technology (IRT®) systems and solutions. endpoint delivers feature-rich, easy-to-customize systems and solutions for clinical trial and supply management in the life sciences. endpoint's proprietary IRT system configuration engine, PULSE®, helps users design and deploy an IRT solution that is customized for their specific needs in as little as four weeks. Since 2009, endpoint has been developing and implementing IRT systems for an array of therapeutic areas in more than 40 countries and in over 30 languages. See how endpoint's flexible IRT solution meets the unique needs of any clinical trial at www.endpointclinical.com.

Education

university of iowa

university of iowa

english

2001-1 - 2005-1 · 4 yrs 1 mo

Meghan Burke's Contact Information

Email

******@***.com

Phone

(**) *** ****

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