Independent Pharmaceutical Industry Consultant (20 Years in Biomedical Research, Clinical Development, Medical Affairs)
Greater New York City Area
16+ years of experience in Clinical Research, Pharmaceuticals and Public Health. 8 years of Pharmaceutical Industry experience. Contributor to pre/post launch activities for key Oncology compounds including Afinitor®, Abraxane®, Revlimid®, Pomalyst®, Opdivo® and Yervoy® as a member of the Global Clinical Development and Medical Affairs/Life-Cycle Management Teams at Novartis Oncology, Celgene Corporation and Bristol-Myers Squibb. * Matrix...
16+ years of experience in Clinical Research, Pharmaceuticals and Public Health. 8 years of Pharmaceutical Industry experience. Contributor to pre/post launch activities for key Oncology compounds including Afinitor®, Abraxane®, Revlimid®, Pomalyst®, Opdivo® and Yervoy® as a member of the Global Clinical Development and Medical Affairs/Life-Cycle Management Teams at Novartis Oncology, Celgene Corporation and Bristol-Myers Squibb. * Matrix Team Leadership - Experience leading International/Virtual and Co-located teams. * Expert communicator with Patients, Caregivers, Healthcare Professionals and Scientists. * People Management - Direct Report and Matrix/Virtual team management * Project Management - Project Specification Development, Clinical Development Strategy, SWOT Analysis, Process Improvement, Organizational Needs Assessments/RACI Development * Phase I-IV Clinical Trial Management Clinical Data Experience: * Created the trademarked name and logo and contributed to system development for Celgene MATRIX™ a web-based CTMS to support Global Medical Affairs Operations for Oncology Investigator Initiated, Cooperative Group and Third Party Studies * EDC System, eCRF, IVRS/IWRS spec/development/UAT, clinical database builds, dashboard development * Experience leveraging epidemiology data and clinical diagnosis coding systems for Clinical Trial Recruitment Planning/Analytics * Pharmacovigilance/Drug Safety Data Review and Reconciliation * Documentum, MS Visio, MS PowerPoint, MS Access, MS Excel, Adobe, SharePoint, Base SAS (beginner), SQL (beginner). End user experience with Oracle Clinical RDC systems, Medidata RAVE, ClinTrial, IMPACT, Tableau, StatTransfer, ICD-9 (beginner), MedDRA and WHO Classification of Diseases. Lisa L. is skilled in: Clinical Trial..., Informatics, EDC Build, Clinical Development, CTMS, Clinical Research, Pharmacovigilance, CRO, Clinical Trials, Project Management, Outcomes Research, Epidemiology, HIPAA, Drug Development, Biotechnology, Clinical Data Management, Databases, Public Health..., Documentum, Medidata, Data Management, Medical Affairs, Regulatory Affairs, Clinical Trial..., Safety Data..., CRO Management, Phase I/Early Clinical..., Global Clinical..., Hematology/Oncology..., Electronic Medical..., Drug Safety, Biomedical Sciences, Bioethics, Research Administration, Clinical Study Design, EMR, Hematology, Clinical Operations, Health Economics and..., Medical..., IVRS, MedDRA, WHO Classification of..., ICD-9, EDC
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