AUDREY BYERS
Georgetown
Summary
Experienced Clinical Data Management Project Manager with expertise in clinical trials data management and database development. Skilled in all stages of the process, from start-up to submission. Recognized for strong interpersonal and communication abilities, as well as a commitment to efficiency. Demonstrates problem-solving skills and a willingness to adapt to new challenges. Self-motivated and analytical, excelling in a collaborative environment. Notable experience with the FDA, including leading the efficacy team in a successful drug re-introduction Advisory Committee Meeting. Also served as a slide handler and backup slide creator for another successful meeting. Played a crucial role in the information requests team for multiple approved drugs. Proficient in database development, maintenance, user acceptance testing (UAT), and conducting trainings using various electronic data capture systems.
Overview
9
9
years of professional experience
Work History
PROJECT MANAGER, CLINICAL DATA MANAGEMENT
Lexitas
09.2024 - Current
- Provide oversight of Clinical Data Leads and Clinical Data Coordinators in the planning, implementation, and closeout of data management activities for clinical research projects
- Ensure that project activities are produced according to the study scope, budget, and timelines
- Oversight of external data management resources and vendors if any data management study activities are being performed by another service provider
- Oversight and review of all database development activities including, but not limited to, eCRF development, Data Validation Specifications development, eCRF Completion Guidelines development, User Acceptance Testing, and Data Management Plan development
- Work actively with the clinical and data management study teams to review study data and ensure data quality
- Identify and escalate any risks to database integrity, study timelines, and resourcing to the appropriate individuals
- Maintain, update, and create SOPs and work instructions
- Responsible for communicating with internal study teams, sponsor study teams, and study stakeholders on data management progress, timelines, issues, and risks
- Participate in and lead client team meetings with respect to data management activities as needed
- Ensure appropriate training to the study team on the use of electronic data capture technology
- Assists with the training of clinical data leads, clinical data coordinators, and new employees
- Budget and forecast for multiple clinical trials conducted and reviewed with CFO and finance teams
- Reviews and provides feedback to the clinical team on multiple study documents
- Including but not limited to vendor specifications, clinical monitoring plan, protocol review, etc…
SENIOR CLINICAL DATA MANAGER
ICON PLC
12.2020 - 09.2024
- Reviews data and managing, issuing, and resolving edit checks and queries
- Creates EDC reports and data review listings for clinical team review
- Creates SAS specification documents for data review
- Performs validation processes for data review reports and documents
- Leads and performs data management tasks
- Leads and performs data reconciliation efforts
- Acts as liaison between Data Management and Programming Teams for updates and edits for external data review documents
CLINICAL DATABASE DEVELOPER/ DATA MANAGER
Supernus Pharmaceuticals
04.2020 - 12.2020
- Developed SOPs for clinical database development, testing, and maintenance
- Created templates for testing plans, testing scripts, and data management guidelines
- Built and set live multiple clinical trials
- Performed mid-study updates for various clinical trials
- Creation and maintenance of clinical databases
- Leads study kick-off clinical database review meetings of database to meet all required standards
- Reviewing data and managing, issuing, and resolving edit checks and queries
- Creates EDC reports and data review listings for clinical team review
- Contributes to the creation, preparation, and updating of data management documents
- Performs EDC user acceptance training for eCRF creation and mid-study updates
- Scheduling and leading data management weekly updates for clinical trials
- Data management lead for implementing and establishing payment processes for clinical trials
- Conducts and maintains medical coding and associated responsibilities
- Manages and collaborates with contractors and external vendors
- Leads and performs data management tasks
- Manages and monitors electronic data capture systems
- Clinical database software developer (IBM Merge)
- Leads and performs study closeout and data reconciliation efforts
CLINICAL DATA MANAGER / CLINICAL DATA SCIENTIST
US WorldMeds
06.2016 - 04.2020
- Leader of efficacy team for successful FDA Advisory Committee meeting
- Team member for the creation of publication specifications and quality control document processes for clinical and biometric data for FDA submissions
- Member of instrumental data analysis and statistical team for editing, creating, and consolidating data and subsequent documents for two, successful NDA submissions to the FDA
- Documented and organized programmed data for drug re-introduction submission to FDA
- Slide handler and backup slide creator for successful FDA Advisory Committee meeting
- Database developer for two clinical trials
- Reviewing data and managing, issuing, and resolving edit checks and queries
- Vendor evaluation
- Creates EDC reports and data review listings for clinical team review
- Contributes to the creation, preparation, and updating of data management documents
- Performs EDC user acceptance training for eCRF creation and mid-study updates
- Scheduling and leading data management weekly updates for clinical trials
- Data management lead for implementing and establishing payment processes for clinical trials
- Creates and maintains payment reporting process for clinical trials
- Conducts and maintains medical coding and associated responsibilities
- Shipping management for investigational and non-investigational products
- Manages and collaborates with contractors and external vendors
- Leads and performs data management tasks
- Conducts and leads trainings for clinical trial electronic data capture systems
- Manages and monitors electronic data capture systems
- Clinical database software developer (IBM Merge)
- Leads and performs study closeout and data reconciliation efforts
Education
Bachelor of Science - Biosystems Engineering
University of Kentucky
Lexington, Kentucky05.2016
Skills
- IBM Merge EDC System
- Zelta-Merative EDC System
- Oracle InForm EDC System
- Veeva EDC System
- Medidata Rave EDC System
- Adobe Pro DC
- TRS Toolbox for Adobe
- Systems Integration
- Microsoft Excel
- Microsoft Word
- Microsoft Outlook
- Microsoft PowerPoint
- Microsoft Project
- Basic AutoCAD
- Microsoft Office
- MedDRA Coding
- WHODrug Coding
Therapeutic Areas
- Inherited Diseases: Sickle Cell Disease, Clinical Data Manager
- Genetic Conditions: Cystic Fibrosis, Clinical Data Manager
- Neurological: Parkinson's Disease, Lead Data Manager and Lead Database Developer
- Opioid Addiction: Opioid Dependence, Lead Data Manager
- Functional Disorders: IBS-C, Efficacy Team Lead
- Ophthalmology: Dry Eye, Retinoid Pigmentosa, Macular Degeneration, Blepharitis, Project Manager, Data Management
Awards And Acknowledgements
- IBM Certified Clinical Database Developer (2020)
- IBM Mid-Study Update Certification (2020)
- American Society of Agricultural and Biological Engineers Member (2015-2017)
- Biosystems and Agricultural Engineering Junior of the Year Award (2015)
- NASA Group Achievement Honor's Award Recipient (2014)
- Women in Mining University of Kentucky Chapter Vice President (2013)
Timeline
PROJECT MANAGER, CLINICAL DATA MANAGEMENT
Lexitas
09.2024 - Current
SENIOR CLINICAL DATA MANAGER
ICON PLC
12.2020 - 09.2024
CLINICAL DATABASE DEVELOPER/ DATA MANAGER
Supernus Pharmaceuticals
04.2020 - 12.2020
CLINICAL DATA MANAGER / CLINICAL DATA SCIENTIST
US WorldMeds
06.2016 - 04.2020
Bachelor of Science - Biosystems Engineering
University of Kentucky
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