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Competencies around Vendor Management, data listing review, and monitoring report review As a clinical program and operations director I have managed various types of programs, projects, and vendors. Contract Research Organizations (CRO) I have performed overall project management of the CRO, managed and reviewed budgets, change orders, patient enrollment and study start-up from the sponsor side. I have also managed central laboratories relative setting up the clinical sites to send samples, tracking shipping of samples, and reviewing sample data. I have also managed the selecting of specialty laboratories for the collection of tissue and other biological material for biomarker. I assured that were provided with the appropriate equipment and trained properly on collection and shipment of samples. Made sure samples were collected and shipped by tracking samples.I have performed standard data listing reviews during a clinical trial as well as data listings and tables for Data Safety and Monitoring Boards (DSMB).I reviewed all monitor reports for North America and Europe. In previous jobs I monitoring reports when problems were suspected with data, or anything related GCP. I am skilled leader of personnel and over 15 years experience of line management.
Clinical Operations And Project Management Various Clients
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Clinical Operations And Project Management Various ClientsRichardson, Tx, Us
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Clinical Operations Consultant Various ClientsClinical Operations And Project Management Various Clients Dec 2017 - Present
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Senior Director Clinical Operations Of A Small 34 Person BiotechKempharm, Inc. Dec 2014 - Dec 2017Celebration, Fl, Us -
Senior Clinical Research AssociateIcon Clinical Research Aug 2013 - Dec 2014Site start-upSite trainingGCP trainingQuality GAP analysisVendor oversightTherapeutic AreasOncologyInfectious DiseaseImmunologyAuto-immune DiseasesPainReproductive MedicineVaccine Development
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Director Of Clinical Operations/Clinical Process ChampionCovidien Aug 2009 - Mar 2013
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Global Trial LeaderWyeth Research 2008 - Jul 2009
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Clinical AffairsChemgenex Pharmaceuticals, Inc. 2007 - 2008Us -
Manager/Program Manager IiGenentech Mar 2004 - Sep 2007South San Francisco, California, Us -
Predictive Medicine ConsultantGlaxosmithkline 2001 - 2004Brentford, Middlesex, GbOncology Biomarker Identification in the Predictive Medicine Group -
Clinical OperationsClinical Operations 1992 - 2001Clients include: GlaxoSmithKline, AstraZeneca, Oncotech, Cambridge Antibody Technologies, Targeted Molecular Diagnostics, Pathogenesys, Genentech, Impath Prior career was 16 years at Burroughs Wellcome as Section Head Drug Information as well as a senior clinical research scientist
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Section HeadBurroughs Wellcome 1987 - 1992
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Clinical Research ScientistBurroughs Wellcome 1977 - 1987
Ed Kirk Skills
Ed Kirk Education Details
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Hope CollegeBiology
Frequently Asked Questions about Ed Kirk
What company does Ed Kirk work for?
Ed Kirk works for Clinical Operations And Project Management Various Clients
What is Ed Kirk's role at the current company?
Ed Kirk's current role is Part-time Clinical Consultant at Clinical Operations and Project Management.
What is Ed Kirk's email address?
Ed Kirk's email address is ek****@****arm.com
What is Ed Kirk's direct phone number?
Ed Kirk's direct phone number is +197263*****
What schools did Ed Kirk attend?
Ed Kirk attended Hope College.
What skills is Ed Kirk known for?
Ed Kirk has skills like Clinical Development, Oncology, Drug Development, Biotechnology, Clinical Research, Infectious Diseases, Fda, Regulatory Submissions, Pharmacovigilance, Program Management, Team Building, Biomarkers.
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