Summary
Overview
Work History
Education
Skills
Certification
Work Availability
Timeline
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Gwendolyn Maddox

Ellicott City

Summary


Knowledgeable clinical operations professional with proven track record in managing clinical research operations and streamlining processes. Demonstrated success in leading teams to enhance operational efficiency and compliance. Adept at strategic planning and fostering collaborative environments. Possesses a proven track record for effectively managing high-impact projects, multi-year multi-million-dollar budgets, federal and commercial grants, and contracts.

Overview

19
19
years of professional experience
5
5
Certification

Work History

Director of Clinical Operations

DLH Corporation
12.2021 - 01.2024
  • Provided oversight of research programs and projects including network clinical coordinating centers, totaling more than $122 million in government and commercial grants and contracts
  • Oversaw project timelines, budgets, cross-functional logistics, and resources
  • Supervised eight Project Directors and Project Managers
  • Ensured project staff were trained for their roles and job assignments and projects were adequately staffed and resourced
  • Conducted regular performance assessments to ensure capabilities and resources aligned with established requirements
  • Ensured all project plans adhered to company policies, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) requirements as applicable
  • Identified program/resource gaps, performed project risk analyses, and implemented solutions
  • Informed senior leadership about time-sensitive activities and important contract deliverables, vendor oversight, quality standards, and risk mitigation
  • Served as a senior member of proposal development teams across cross-functional areas of the company

Project Director

DLH Corporation
12.2010 - 12.2021
  • Managed $200 million in revenue across government and commercial grants and contracts, including a high-level research operations center with a $140 million multi-year budget
  • Successfully managed eleven task orders under a government Indefinite Delivery, Indefinite Quantity (IDIQ) contract
  • Led and supported business development efforts to secure grants and contracts
  • Built and maintained strong relationships with federal clients in support of company contracts
  • Had responsibility for all phases of the project life cycle including procurement, communications, budget development, information management, and contract/subcontract engagements
  • Ensured compliance with applicable Federal regulations and policies
  • Served as Project Director for: The Sexually Transmitted Infections Clinical Trials Group (STI-CTG) Coordinating Center, the Mexican Emerging Infectious Disease Clinical Research Network (LaRed), and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)

Associate Director/Leadership Group Manager

DLH Corporation (formerly Social & Scientific Systems, Inc.)
09.2008 - 12.2010
  • Planned, managed, and implemented major operations in the areas of performance evaluation, communications, website, and data management to ensure timeliness and accuracy of multiple processes vital to the IMPAACT Network and its leadership
  • Coordinated the preparation and review of official documents for submission to the Division of AIDS, the IMPAACT Network, and Network Investigators
  • Provided support and direction on key processes related to Network and Operations Center performance evaluation
  • Provided quality control for documents developed and distributed by the IMPAACT Network

Executive Director

The Foundation for Post-Acute & Long-Term Care Medicine (formerly AMDA Foundation)
07.2005 - 07.2008
  • Provided strategic leadership and management oversight to the organization
  • Created an annual budget exceeding $1 million from various revenue sources
  • Provided resources to guide the Foundation in the development of its staff, policies, strategic planning, and other management issues
  • Directed and oversaw fundraising including annual giving campaigns
  • Provided overall grants management and administration
  • Developed and maintained strategic business and organizational relationships
  • Identified potential funding opportunities and developed strategies to secure funds
  • Directed and supervised National office staff
  • Provided staff support to the Board of Directors

Education

Master of Science - Management

University of Maryland Global Campus

Bachelor of Arts - Health Science and Policy

University of Maryland, Baltimore County

Skills

  • Program Management
  • Project Management
  • Program Development
  • Strategic Planning
  • Budget Development
  • Resource Allocation
  • Financial Forecasting
  • Solution Development
  • Process Improvement
  • Performance Management
  • Corporate Communications
  • Cross Functional Leadership
  • Grants Administration
  • Contract Management
  • Business Development
  • Clinical Trial Management

Certification

  • Project Management Professional (PMP) - Project Management Institute
  • CITI Program Certifications
  • GCP for Clinical Trials with Investigational Drugs and Biologics
  • FDA Inspections: From Site Preparation to Response
  • Biomedical Responsible Conduct of Research
  • Biomedical Comprehensive
  • Clinical Research: An Introduction

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Director of Clinical Operations

DLH Corporation
12.2021 - 01.2024

Project Director

DLH Corporation
12.2010 - 12.2021

Associate Director/Leadership Group Manager

DLH Corporation (formerly Social & Scientific Systems, Inc.)
09.2008 - 12.2010

Executive Director

The Foundation for Post-Acute & Long-Term Care Medicine (formerly AMDA Foundation)
07.2005 - 07.2008

Bachelor of Arts - Health Science and Policy

University of Maryland, Baltimore County

Master of Science - Management

University of Maryland Global Campus

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