Michelle Walters
Cocoa Beach,United States
Summary
Associate Director of Site Activation leading high-profile clinical trials with a focus on accelerating site activations and enhancing compliance. Successfully completed the COVID-19 vaccine trial start-up in 3.5 months, while managing operations in 50+ countries, driving efficiency, and ensuring timely delivery of regulatory submissions and approvals.
Overview
1
1
Certification
29
29
years of professional experience
Work History
Associate Director, Site Activation Manager (SAM)
IQVIA
, United States
01.2021 - Current
- Spearheaded global site activation activities for COVID-19 trials across hundreds of sites, completing the COVID-19 vaccine trial start-up in 3.5 months.
- Led study start-up leadership and oversight for high-profile trials and site activations from award to open enrollment, ensuring compliance and timeliness.
- Streamlined clinical trial site activations to exceed project metrics by implementing efficient processes aligned with project scope, budget, KPIs, and timelines.
- Leads operational teams in over 50 countries, preparing and reviewing technical documents, defining regulatory strategy and parameters for submissions and authorizations, and a plan of action for the start-up activation strategy.
- Managed global and regional site activation managers and entire global start-up teams, mentoring site activation managers to enhance team effectiveness.
- Directed multiple trial programs in over 50 countries as an integral member of the study management team, resulting in on-time, high-quality, and fully compliant delivery of study start-up. Including close collaboration with therapeutic heads.
- Improved project oversight and compliance measures across all phases by maintaining data integrity and real-time access to all internal systems (CTMS, DrugDev), databases, and project tracking tools.
Global RSU Manager/Site Activation Manager
IQVIA
, United States
11.2018 - 12.2020
- Led all phase III start-up activities for hemophilia clinical trials across 26 sites in the U.S. and Canada, overseeing site identification, contract negotiations, and RA/EC submission.
- Accelerated start-up activation for sickle cell disease clinical trials across 15 countries, including Canada, Jamaica, and the U.S., managing activities from phase I to III.
- Reduced start-up timeline by executing the RSU management plan and leading communication across multiple countries to deliver the agreed project scope.
- Developed global study start-up strategy and timelines, coordinating site identification, RA/EC submission, clinical trial agreement, and budgeting within dedicated region.
Associate RSU Manager
IQVIA
, United States
12.2015 - 10.2018
- Executed start-up and maintenance activities for assigned global projects, aligning with RSU strategy to ensure timely delivery.
- Accelerated submission processes and regulatory approvals by classifying submission parameters and mitigating risks.
- Collaborated across regional and global RSU teams to deliver project milestones on schedule within RSU management frameworks.
- Played a key role in enhancing global regulatory intelligence, analyzing and disseminating data to guide assigned studies and inform broader company strategies.
- Developed strong relationships with key clients, establishing the organization as a trusted partner for ongoing collaboration.
Senior Country Approval Specialist-Site Intelligence and Activation
PPD DEVELOPMENT, LP
Austin, United States
08.2015 - 12.2015
- Led all submission meetings as the primary point of contact for investors, central country, and site IRB approvals.
- Created and presented regulatory compliance review packages, collaborating with local SIA to facilitate seamless submission aligned with global project strategy.
- Led regulatory start-up project, managing local submissions to ensure compliance with global standards.
- Ensured strict adherence to site activation compliance and timeline for the submission process of sites and study.
- Developed country- and site-specific patient information sheets and informed consent forms (ICF).
Supervisor Administrative Services – Phase I
PPD DEVELOPMENT, LP
Austin, United States
10.2013 - 07.2015
- Headed end-to-end administrative operations for Phase 1 clinical studies, ensuring accurate tracking of costs, maintenance of Curriculum Vitae records, and timely updates to work practice documents (WPDs) and standard operating procedures (SOPs).
- Supervised and trained a team of project assistants, enhancing their proficiency in study documentation and regulatory compliance processes.
- Executed hiring, budgeting, and management of direct reports in administrative services to maintain operational efficiency.
- Partnered with project managers to optimize study start-up processes, streamlining regulatory documents for Phase 1 clinical studies and minimizing delays in trial initiation.
- Collaborated with pharmaceutical clients and institution review board (IRB) to ensure compliance with study requirements.
Senior Project Assistant-Phase I
PPD Development, LP
Austin, United States
01.2012 - 01.2013
Project Assistant-Phase I
PPD Development, LP
Austin, United States
01.2011 - 01.2012
Project Coordinator- Phase II-IV
Comprehensive Research Group
St. Anthony, United States
01.2009 - 01.2010
Certified Clinical Research Coordinator- Phase II-IV
Twin Cities Clinical Research
Brooklyn Center, United States
01.2003 - 01.2008
Certified Nursing Assistant
Shalom Home West Nursing Home
St. Louis Park, United States
01.2002 - 01.2003
Medical Records Coordinator
Fortis Benefits Insurance Company
Edina, United States
01.1998 - 01.2003
Education
Bachelors of Applied Arts and Science -
Lamar University
Beaumont, TXSkills
- Regulatory & Start-Up Strategy
- Study Start-Up Planning
- Start-Up Timelines
- Start-up acceleration
- Clinical Development
- Clinical Research
- Clinical Trials
- ICH-GCP Guidelines
- FDA Regulations
- Compliance
- Risk Assessment
- Process Improvement
- Change Management
- CTMS
- DrugDev
- Veeva Vault
- Medidata RAVE
- Study
- ETMF
- Project Coordination
- Budget Management
- Stakeholder management
- Cross-regional collaboration
- Team Leadership
- Team Building
- Strategic Thinking
- Activation Trends
- Hemophilia
- Sickle Cell Anemia
- Graft Vs Host Disease
- Prostate Cancer
- Oncology
- Cardiovascular
- Diabetes
- Kidney Disease
- COVID-19
- Alzheimer's Disease
- Weight Loss
- Word
- Excel
- PowerPoint
- Microsoft Project
- PowerPoint
- Microsoft Project
Certification
- Project Management Professional (PMP), Project Management Institute (PMI), 01/23
- Certified Clinical Research Coordinator, Academy of Clinical Research Professionals
Personal Information
Title: PMP
Areas Of Expertise
Regulatory & Start-Up (RSU) Strategy, Clinical Development, Study Start-Up Planning, Start-Up Timelines, Acceleration Start-up and Activation, Clinical Research, Risk Assessment, Process Improvement, Change Management, Compliance, ICH-GCP Guidelines, FDA Regulations, Clinical Trials, Investigative Sites, Activation Trends, Strategic Thinking, Team Building, Stakeholder Relationship, Cross-Regional Communication, Talent Development, Financial Accountability, Strong Organizational Skills, Hemophilia, Graft Vs Host Disease, Prostate Cancer, Sickle Cell Anemia, Schizophrenia, Oncology, Cardiovascular, Diabetes, Kidney Disease, COVID-19, Alzheimer's Disease, Weight Loss, CTMS, DrugDev, Study, eTMF including Veeva Vault and Medidata RAVE, Word, Excel, PowerPoint, Microsoft Project
Timeline
Associate Director, Site Activation Manager (SAM)
IQVIA
01.2021 - Current
Global RSU Manager/Site Activation Manager
IQVIA
11.2018 - 12.2020
Associate RSU Manager
IQVIA
12.2015 - 10.2018
Senior Country Approval Specialist-Site Intelligence and Activation
PPD DEVELOPMENT, LP
08.2015 - 12.2015
Supervisor Administrative Services – Phase I
PPD DEVELOPMENT, LP
10.2013 - 07.2015
Senior Project Assistant-Phase I
PPD Development, LP
01.2012 - 01.2013
Project Assistant-Phase I
PPD Development, LP
01.2011 - 01.2012
Project Coordinator- Phase II-IV
Comprehensive Research Group
01.2009 - 01.2010
Certified Clinical Research Coordinator- Phase II-IV
Twin Cities Clinical Research
01.2003 - 01.2008
Certified Nursing Assistant
Shalom Home West Nursing Home
01.2002 - 01.2003
Medical Records Coordinator
Fortis Benefits Insurance Company
01.1998 - 01.2003
Bachelors of Applied Arts and Science -
Lamar University