Kate Caldwell work email
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Kate Caldwell personal email
I have over sixteen years of clinical development experience ranging from pre-clinical animal studies to Phase 3 studies. My concentrated area of expertise is clinical study start-up and amendment management, using my regulatory and strategic thinking skills to manage the process from site feasibility to final approval for site study participation.
Caldwell Clinical Consulting
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Project ManagerCaldwell Clinical Consulting Oct 2009 - PresentSouth Royalton, VermontManagement of CRO and Sponsor start-up processes for NA and ROW Phase II and III clinical studies to meet timelines, assure corporate goals are met, and site relationships are enhanced.
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Global Regulatory And Start-Up LeadIqvia (Contract) Jan 2017 - Dec 2017Research Triangle ParkOversee the execution of Start Up and/or study regulatory Maintenance for multi-site, global projects during initial start-up and maintenance phase; determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support execution of agreed upon management plan.
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Compliance OfficerDartmouth-Hitchcock Apr 2016 - Dec 2016Lebanon, New HampshireProvided institutional monitoring and quality assurance support to assure regulatory compliance for federally sponsored and IND/IDE Sponsor/Investigator studies -
Clinical ManagerVertex Pharmaceuticals Oct 2009 - Feb 2016 -
Project ManagerPpd Jun 2007 - Jul 2009Rtp, NcClinical trial conduct project management, with emphasis on study start-up, feasibility studies, and site relationships. -
Regulatory Affairs SpecialistIcagen Jun 2000 - Jun 2007Rtp, NcMy job requirements grew as Icagen's development of a novel sickle cell disease drug progressed, with my responsibilities spanning from start-up, site relationship building, SOP development and training, clin ops, data management, safety reporting management, protocol and document development, vendor management, patient outreach initiatives, and planning marketing and branding strategies.
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ResearcherGlaxo Wellcome Inc. Oct 1997 - Dec 1999Rtp, NcAntiviral research - I conducted a laboratory testing program to identify potential compounds targeting resistant HIV strains, developed antibody assay to allow more precise testing and higher sampling numbers, PCR, calculation of data and presentation of results at team meetings. I was also part of a laboratory team to support an acyclovir OTC indication for Herpes 2 sufferers.
Kate Caldwell Skills
Kate Caldwell Education Details
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Biological Sciences And English Literature -
Bachelor Of Science (B.S.)
Frequently Asked Questions about Kate Caldwell
What company does Kate Caldwell work for?
Kate Caldwell works for Caldwell Clinical Consulting
What is Kate Caldwell's role at the current company?
Kate Caldwell's current role is Global Regulatory and Start-Up Lead.
What is Kate Caldwell's email address?
Kate Caldwell's email address is ca****@****gen.com
What schools did Kate Caldwell attend?
Kate Caldwell attended University Of Vermont, University Of Vermont.
What are some of Kate Caldwell's interests?
Kate Caldwell has interest in Politics, Education.
What skills is Kate Caldwell known for?
Kate Caldwell has skills like Clinical Research, Clinical Development, Informed Consent, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Leadership, Management, Cro, Clinical Trials, Gcp, Microsoft Excel.
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Kate Caldwell
Greater Philadelphia -
3erm.com, gmail.com, gmail.com
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2draftfcb.com, fcb.com -
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