Summary
Overview
Work History
Education
Skills
PPD Quarterly Peak Performance Award
Candidate
Timeline
SoftwareDeveloper
Deanne Hughes

Deanne Hughes

Clinical Research Professional
Milford,OH

Summary

Accomplished Clinical Research and Regulatory Professional adept in global site activations and cross-functional collaboration, ensuring project milestones are met with precision. Skilled in effective communication and process orientation with a high level of attention to detail. Excels in leading teams to exceed sponsor expectations, demonstrating a strong blend of strategic planning, and problem-solving capabilities.

Overview

26
26
years of professional experience

Work History

Start Up Team Manager

PPD
11.2018 - Current
  • Oversees all aspects of global site activations
  • Conducts protocol amendment lead activities for country and site level amendment implementations.
  • Collaborates with cross-functional departments to meet project milestones
  • Leads multiple projects and amendments for global projects,
  • Ensures all start up deliverables meet the contracted and sponsor's expectations, providing accurate projections, reports and updates, and ongoing risk assessments
  • Serves as the primary start up or amendment contact for the sponsor and the internal project team.


Site Activation and Maintenance Manager

MEDPACE CRO
08.2014 - 10.2018
  • Efficiently manages and successfully executes all aspects of global regulatory start-up according to Sponsor specifications
  • Maintains regulatory submissions start-up timelines for multiple studies at a time
  • Independently interacts with Sponsors, clinical research sites, Institutional Review Boards (IRBs)/ Ethics Committees (ECs), regulatory agencies and internal study teams
  • Provides regulatory submissions guidance and advice to internal study teams
  • Develops study specific Informed Consent Forms
  • Provide quality checks of all submission documents
  • Act as the Regulatory Submissions representative during Bid defenses, general capability meetings and audits
  • Provide oversight of Regulatory Submissions Coordinators and Clinical Trial Assistants

Clinical Research Site Manager

North Cliff Consultants
09.2010 - 07.2014
  • Managed day to day activities of the Clinical Research Department
  • Managed all aspects of study development and study execution (including but not limited to responding to RFP's, generating study budgets, managing client negotiations, conducting and attending client presentations, protocol development, creation of recruitment material, selection of study teams, risk mitigation, and subject retention plans)
  • Managed staff of 11 (Clinical Study Managers and Clinical Coordinators) including the conduction of annual performance evaluations.
  • Acted as Principle Investigator or Sub Investigator on Clinical Research Studies
  • Developed and implemented Clinical Department Standard Operating Procedures
  • Developed and implemented Clinical Department Guidance Documents
  • Developed budgets and presented quotes to Sponsors
  • Created the "Clinical Coordinator in Training Program"
  • Conducted training sessions for staff
  • Instrumental in the development of a Company Clinical Process Map
  • A member of the Clinical Project Leaders group, specifically responsible for strategic planning and Clinical Coordinators development and training.


Director, Clinical Project Management /Senior Client Relationship Manager

Schulman and Associates, IRB
04.1999 - 05.2010
  • Successfully developed and managed a team of Clinical Project Managers and Client Relations Managers overseeing client based, clinical study review and approval through the IRB process
  • Successfully developed and managed dedicated Translation Team that processed all translated document needs for clients
  • Supervised and ran day to day operations of 5 key Organizational Teams (Amendments, Product Safety, Recruitment, Translations, and Clinical Project Management/ Client Relations) consisting of 25 team members
  • Conducted presentations at Investigator Meetings (presentation titled "Working with the IRB")
  • Attended annual DIA Conferences
  • Traveled with the Business Development Team for purposes of generating new business and retention of current clients
  • Provided company Web Portal demonstrations for clients
  • Created Organizational Performance Standards for internal departments
  • Organized and managed the internal "Forms Committee" (responsible for revision and enhancement of all company forms being used on the company website)
  • Conducted interviews, performance evaluations, terminations and disciplinary action meetings
  • Actively participated in weekly management meetings (provided Organizational Team updates and acted as liaison between Management and Organizational teams)
  • Served as a liaison and single-point of contact between Schulman, IRB and clients including pharmaceutical companies, Contract Research Organizations (CRO), Site Management Organizations (SMO), and Clinical Research sites during all aspects of their study participation

Education

Bachelor of Science in Nursing - Nursing

University of Cincinnati
Cincinnati, OH
05-1995

Certificate - Project Management

University of Cincinnati
Cincinnati, Ohio
12-2010

Skills

    Effective verbal and written communication

    Detail oriented

    Problem solver

    Team player

    Customer focused

    Solution driven

PPD Quarterly Peak Performance Award

My Team was awarded the Q2, 2020 Peak Performance Award for our commitment, team spirit and going the extra mile which led to the success of an important COVID-19 study. Our Team's tremendous performance led to the success in getting this COVID-19 treatment to patients quickly to help make a difference in this global health crisis.

Candidate

Deanne Hughes is a customer focused Clinical Research Professional with more than 20 years of experience in the clinical research industry. Her vast experience includes roles in a variety of companies such as 10 years at an Institutional Review Board, 4 years at a Clinical Research Site and a combined 10 years at two different Clinical Research Organizations. Deanne has a broad range of experience managing sites from start-up throughout the life of their study participation. She has been instrumental in the conduct of phase I, II, III, and IV trials across North America, Latin America and Europe. Deanne excels at building exceptional client relations by focusing on effective communication, customer service and going over and beyond to meet the project milestones and client expectations. The remarkable rapport Deanne has with clients is evident by the numerous requests she receives to be assigned to their projects. In summary, Deanne Hughes is a valuable, effective and productive individual who has a positive impact on any project team as a knowledgeable, energetic and collaborative team player.

Timeline

Start Up Team Manager

PPD
11.2018 - Current

Site Activation and Maintenance Manager

MEDPACE CRO
08.2014 - 10.2018

Clinical Research Site Manager

North Cliff Consultants
09.2010 - 07.2014

Director, Clinical Project Management /Senior Client Relationship Manager

Schulman and Associates, IRB
04.1999 - 05.2010

Bachelor of Science in Nursing - Nursing

University of Cincinnati

Certificate - Project Management

University of Cincinnati
Deanne HughesClinical Research Professional