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Sharon Location
Durham, NC, US
Sharon Work
Country Approval Specialist @ (May 2022 - Present)
Regulatory Start Up Specialist I @ (February 2016 - April 2022)
Sr. Patient Data Coordinator @ (July 2014 - November 2015)
Clinical Documentation Coordinator @ (May 2012 - July 2014)
Clinical Records Coordinator @ (August 2011 - May 2012)
Document Management Specialist @ (September 2008 - March 2010)
Clinical Trial Coordinator @ (May 2008 - September 2008)
File Maintenance Technician @ (January 2000 - January 2008)
Coordinator @ VANJ Health Care System (January 1992 - January 1999)
Sharon Education
Strayer University-North Carolina
(Business Administration and Management, General)
2012
Sharon Skills
Regulatory Agencies
Research and Development (R&D)
Vault
Veeva Vault
Tracking Systems
SharePoint
Microsoft Excel
Quality Assurance
Critical Thinking
Interpersonal Skills
Teamwork
Internal Audits
Informed Consent
Written Communication
Project Documentation
Organization Skills
Handle Confidential Information
Computer Literacy
Problem Solving
Multiple Sites
Coaching & Mentoring
Clinical Quality
Harmonization
Terminology
Communication
Attention to Detail
Pharmaceutical Industry
Document Management
Clinical Trials
GCP
Sop
Oncology
FDA
CRO
Clinical Development
Regulatory Submissions
Regulatory Affairs
GMP
CTMS
21 CFR Part 11
Change Control
ICH-GCP
Biotechnology
EDC
Data Management
Clinical Monitoring
Drug Development
Clinical Trial Management System (CTMS)
Good Clinical Practice (GCP)
Standard Operating Procedure (SOP)
Sharon Summary
Sharon, based in Durham, NC, US, is currently a Country Approval Specialist at PPD Group. Sharon brings experience from previous roles at IQVIA, Biogen, Salix Pharmaceuticals and Bayer HealthCare. Sharon holds a Strayer University-North Carolina. With a robust skill set that includes Regulatory Agencies, Research and Development (R&D), Vault, Veeva Vault, Tracking Systems and more. Sharon has 2 emails on RocketReach.
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