Deirdre Brewton
Louisburg,NC
Summary
Experienced Clinical Data Scientist with a strong track record of leading successful data science projects. Detail-oriented professional with excellent communication and project management skills, capable of effectively handling multiple tasks in fast-paced environments. Proactive approach in identifying and addressing issues, with a focus on optimizing processes and supporting team objectives.
Overview
18
18
years of professional experience
Work History
Clinical Data Science Lead
ICON Clinical Research
11.2023 - Current
- Lead Data Management (DM) for clinical studies, overseeing day-to-day activities and serving as the primary point of contact
- Manage and delegate DM tasks to study team members, ensuring timely delivery of study milestones
- Develop and implement electronic case report form (eCRF) specifications, edit checks, and data review processes
- Spearhead the creation and maintenance of the Data Management Plan (DMP) and Study Specific Procedures (SSPs), ensuring compliance and team-wide training
- Establish and monitor study-specific metrics and reporting, maintaining audit-ready DM files
Setup Clinical Data Lead
ICON Clinical Research
06.2022 - 11.2023
- Led study setup activities, including design and testing of eCRF specifications, edit checks, and data management processes
- Co-authored Data Management Plan (DMP) and Study Specific Procedure (SSPs), overseeing their distribution and ensuring team training on procedures
- Maintained audit-ready DM files, ensuring compliance with regulatory standards
Clinical Data Lead
ICON Clinical Research
12.2021 - 06.2022
- Oversaw daily data management activities for clinical trials, ensuring adherence to project timelines and quality standards
- Led the design, implementation, and testing of eCRFs, edit checks, and data listings
- Developed and maintained the DMP and SSPs, ensuring proper training and compliance
- Ensured study metrics and progress reporting were consistently updated, with files maintained in an audit-ready state
Associate Clinical Data Team Lead
PPD
12.2020 - 12.2021
- Coordinated data cleaning efforts and delegated tasks to ensure adherence to quality standards and timely project delivery
- Contributed to database specifications, database builds, and user acceptance testing
- Monitored study metrics, provided project status reports, and participated in team and client meetings
- Delivered study-specific training to junior associates and ensured compliance with project guidelines
Senior IRT Systems Support Analyst
PPD
03.2016 - 12.2020
- Managed end-user support for Interactive Response Technology (IRT) systems, resolving issues via calls, emails, and Jira ticketing system
- Led a team of support analysts, ensuring optimal system performance and user experience
- Administered IRT system access management, troubleshooting issues related to access provisioning and security
- Maintained a strong knowledge of GCP, GDP, and regulatory requirements, ensuring compliance with clinical trial protocols
- Trained and mentored new hires, ensuring adherence to IRT system processes
IRT Systems Support Analyst
PPD
04.2014 - 03.2016
- Managed IRT system updates, quality checks, and documentation, ensuring proper implementation
- Authored and reviewed IRT System Support Directives and Implementation Directives
- Served as the Subject Matter Expert (SME) for Medidata Balance IRT projects and provided on-call weekend support
- Contributed to study kick-off meetings and trained new hires on IRT system processes
IRT Systems Support Associate
PPD
06.2012 - 04.2014
- Provided high-quality customer service for internal and external IRT system users, ensuring issue resolution and follow-up
- Logged and tracked support tickets, proposed process improvements, and contributed to their implementation
- Coordinated team meetings, drafting agendas and publishing minutes on SharePoint
EDC Systems Support Specialist
PPD
01.2007 - 06.2012
- Provided support for clinical trials using Electronic Data Capture (EDC) systems, ensuring compliance with 21 CFR Part 11 regulations
- Managed EDC site assessments during study start-up, and facilitated troubleshooting and issue resolution for investigative sites
- Oversaw EDC hardware provisioning, including vendor management and logistical support for third-party deliveries
Education
Diploma - Clinical Research Administration
Durham Technical Community College
Durham, NC05.2009
Bachelor of Science - Biology
Saint Augustine’s University
Raleigh05.1992
Skills
- Data Quality Assurance
- Data Analysis in Trials
- Understanding of GxP and Good Clinical Practice
- Cross-Functional Collaboration
Timeline
Clinical Data Science Lead
ICON Clinical Research
11.2023 - Current
Setup Clinical Data Lead
ICON Clinical Research
06.2022 - 11.2023
Clinical Data Lead
ICON Clinical Research
12.2021 - 06.2022
Associate Clinical Data Team Lead
PPD
12.2020 - 12.2021
Senior IRT Systems Support Analyst
PPD
03.2016 - 12.2020
IRT Systems Support Analyst
PPD
04.2014 - 03.2016
IRT Systems Support Associate
PPD
06.2012 - 04.2014
EDC Systems Support Specialist
PPD
01.2007 - 06.2012
Diploma - Clinical Research Administration
Durham Technical Community College
Bachelor of Science - Biology
Saint Augustine’s University
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