Functional Skills

Clinical Operations
Compliance and risk
Cybersecurity
Data Strategy
Regulatory Compliance
Technology Strategy
Quality Management
Clinical Data Management
Data Governance
Incident Response

Software Skills

Google Sheets
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
Microsoft Word
Outlook
Sharepoint
SurveyMonkey

Certifications

CHSECertified HIPAA Security Expert
CISMCertified Information Security Manager
MLSMedical Laboratory Scientist
MTMedical Technologist

Sector Experience

Healthcare
Business Services
Social & Public Sector
Technology
Life Sciences & Pharma

Languages

English
1
jobs

Jobs Completed

33
hours

Total Hours Logged

33
years

Years of Experience

4/20

Member Since


Experience

 
IPATIENTAXIS/GRANITE Management Consulting
SR. PRINCIPAL ADVISOR
06/2020 - Present
PROVIDE SENIOR ADVISORY SERVICES AND SUPPORT TO CEO FOR PATIENT INFORMATION DATA AGGREGATION ORGANIZATION IN SUPPORT OF CLINICAL TRIAL ORGANIZATIONS OPERATIONS

Sybil Ingram, Ph.D., LLC Management Consulting
SR. PRNCIPAL ADVISOR
04/1992 - Present
INFOSEC/CYBERSECURITY SPECIALIST, GOVERNANCE/REGULATORY/COMPLIANCE ADVISOR FOR CLINICAL/MEDICAL DEVICE/PHARMA/BIOTECH ORGANIZATIONS, PUBLIC HEALTH EMERGENCY PREPAREDNESS SPECIALIST (TO INCLUDE COVID-19) AUDITOR, STRATEGIC PLANNER, HIPAA, PRIVACY ENGINEER

See resume for more details.

ALL HANDS CONSULTING Management Consulting
COVID RECOVERY PLANNER
03/2021 - 08/2021
INCIDENT COMMAND STRUCTURE RECOVERY PLANNER FROM THE COVID PANDEMIC FOR THE BALTIMORE CITY HEALTH DEPARTMENT

ATLANTA PUBLIC SCHOOLS/RAUSCH Management Consulting
PROJECT MANAGEMENT
03/2021 - 06/2021
MANAGE FOUR AUDITORS AND CREATE FINAL REPORT IN SUPPORT OF ATLANTA PUBLIC SCHOOLS COVID READINESS /RETURN TO SCHOOLS (72 SCHOOLS) AUDIT

AMGEN/BTG Engineering
QUALITY MANAGEMENT SYSTEMS CONSULTANT
01/2020 - 12/2020
PROVIDE ADVISORY SERVICES, AUDITS AND REPORTING FOR ELECTRONIC AND NON-ELECTRONIC DRUG DELIVERY SYSTEM FOR BIOSIMILAR PHARMACEUTICALS PER 21 CFR 820 (COMPLAINTS, ROOT CAUSE ANALYSIS REPORTING, CAPAS)

BOSTON SCIENTIFIC/MEC Operations
QUALITY MANAGEMENT SYSTEMS ENGINEER
09/2018 - 09/2019
ESTABLISH QUALITY MANAGEMENT SYSTEM FOR PATHOLOGY LABORATORY; PERFORM, CONDUCT AND REPORT FULL HIPAA AUDIT ( ELECTRONIC DATA INTERFACES, SECURITY, PRIVACY)

Centers for Disease Control and Prevention Operations
Compliance, QMS, Health Communications, InfoSec Specialist
07/2004 - 05/2017
Sr. Compliance Specialist for the Strategic National Stockpile
Sr. Quality Management System Specialist, BL1 & 2 Laboratories
Sr. Health Communications Specialist, Zika and Opioid Epidemics
Sr. INFOSEC Consultant for CDC CISO