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Information Systems professional with extensive knowledge supporting the Pharmaceutical Research and Development environments Phase I through Phase III. Supported clinical and vaccines filings with increasing levels of responsibility focused on systems management and decommissioning, data migration, data reporting, data collection, data analytics, outsource transition, outsource management, and audit and inspection readiness.Key clients include clinical research, clinical pharmacology and data management. Ability to effectively manage diverse situations ensuring successful strategic outcomes for Research and Development and the Information Technology Organizations.
K&L Consulting Services, In
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Project ManagerK&L Consulting Services, InCollegeville, Pa, Us
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Senior Medical Account ManagerMerck 2008 - 2014West Point, PennsylvaniaResponsible for leadership of clinical data migration of multiple compounds from acquired companies, academic studies, legacy database and external databases, to Merck data repository in preparation for filings. Managed over 75 migrations across 8 compounds from megatrials to clinical pharmacology trials. • Managed outsource staff, contracts and budgets. Guided clinical and project management • Reduced migration budget by 50% over a 4 year period. • Established cross functional standard procedures for migration process• Implemented authorship of cross functional SOPs in support of migrations.• Lead consultant to clinical teams considering migration. • Consulted with several project teams responsible for decommissioning legacy clinical systems.• Guided the IT team in the balance of system decommissioning with continued data access. • Participated on the Merck / Schering Plough Integration Team. * Analyzed Schering Plough and Merck clinical systems to select future corporate system.• Led consultant contract to analyze Clinicals’ opportunities through use of Data Analytics. • Partnered with internal inspection team to implement efficiencies in the inspection pocess. Reduced redundant effort to prepare and respond to audit and inspection teams by 75% while maintaining process and communication consistency. • Collected data migration requirements for future Clinical Trial Management System. -
Medical Account Manager, Clinical PharmacologyMerck & Co 2001 - 2008West Point, PennsylvaniaResponsible for global development, testing, delivery and support of clinical pharmacology trial collectors. Managed a worldwide staff in the delivery of 120 new trial collectors annually. Account manager to the VP of Clinical Pharmacology• Reduced time to develop collector from an average of 3 weeks to min of 5 days.• Co-Led worldwide seminar with clinical trial physicians and staff to collect Phase I requirements• Partnered with IT and business in implementation of future technology seminars and pilots with vendors.• Sponsored team that developed automated testing model that reduced testing by 75% percent.• Implemented a 24X7 support model for first-in-man studies.• Led cross functional Clinical Pharmacology improvement meetings with Clinical, IT, Data Management, Statistics. • Transitioned staff to outsourced development model while retaining deliverable quality and timelines.
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Medical Systems ManagerMerck & Co 1998 - 2001Blue Bell, PennsylvaniaMedical Systems Manager 1998 – 2001Responsible for global development, testing, delivery and support of Phase III clinical trial data trial collectors. Managed a staff in requirements gathering, JAD sessions, testing, development of SOPs and standard design instructions, and unit testing. Provided all required year-end reviews, mentoring, skills assessments. • Developed automated testing tools which reduced redundant unit testing. • Chaired worldwide technical programming meetings
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Senior Medical Programming SpecialistMerck & Co 1993 - 1998Blue Bell, PennsylvaniaResponsible for Clinical / Vaccine Trial Management Systems Support, the “Y2K” effort, and the delivery of filing reports for over 30 drug and vaccine programs in seven therapeutic areas and seven database structures. Supervised staff of 45 worldwide SAS programmers and systems engineers. Provided all required year-end reviews, mentoring, skills assessments.
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Medical Programming SpecialistMerck & Co 1990 - 1993Blue Bell, PennsylvaniaSupervised staff of 15 US based SAS programmers (employees/contractors) ensuring delivery of filing reports for over 30 drug and vaccine programs in seven therapeutic areas and seven database structure. Provided all required year-end reviews, mentoring, skills assessments.
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Clinical/Senior Clinical Trial Sas Programming AnalysitMerck & Co 1985 - 1990Blue Bell, PaClinical/Senior Clinical Trial SAS Programming Analyst 1985 – 1990Senior SAS Programmer responsible for requirements collection and development of SAS filing reports for multiple drugs and vaccines preparing for filing. Senior department trainer. Represented Merck in Sweden in the assessment and successful data migration of Merck’s first external drug compound. Stepped in for management as required
Deborah Lemmel Wilson Skills
Deborah Lemmel Wilson Education Details
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Ms Computer Science
Frequently Asked Questions about Deborah Lemmel Wilson
What company does Deborah Lemmel Wilson work for?
Deborah Lemmel Wilson works for K&l Consulting Services, In
What is Deborah Lemmel Wilson's role at the current company?
Deborah Lemmel Wilson's current role is Project Manager.
What is Deborah Lemmel Wilson's email address?
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What is Deborah Lemmel Wilson's direct phone number?
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What schools did Deborah Lemmel Wilson attend?
Deborah Lemmel Wilson attended East Stroudsburg University Of Pennsylvania, Villanova University.
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What skills is Deborah Lemmel Wilson known for?
Deborah Lemmel Wilson has skills like It Project And Program Management, Pharmaceutical Industry, It Strategy, It Outsourcing, It Management, It Audit, It Solutions, Department Budgeting, Budget Monitoring, Performance Management, Personal Development, Clinical Pharmacology.
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