Joyce Lynn Bean
Doylestown,PA
Summary
Highly motivated Healthcare professional with 21 years of medical business experience in groundbreaking, global clinical research. Joyce’s experience in the Contract Research Organization (CRO) Industry as a Data Coordinator, Project Assistant, and TMF Lead II. Clinical Research Therapeutic Areas to include Cardiology, Oncology, and Contrast Agents in accordance with the work performed by Medical Imaging Service line.
Overview
21
21
years of professional experience
Work History
TMF Lead II
Syneos Health
08.2022 - 03.2026
- Presents in Trusted Process meetings, as TMF Subject Matter Expert (SME)
- Prepares and participates in project-specific audits/inspections to ensure ongoing readiness
- Facilitates monthly meetings to provide metrics to the Sponsor and Project Team
- Monitors TMF completeness by initiating Quarterly Completeness Checks
- Works together with the Project Lead and Functional Leads to ensure TMF documentation is submitted in a timely manner
- Reports on all non-compliance issues
- Provides timelines to the Project Team for the TMF Shipment, final Completeness Checks, document submissions, TMF Export, and shipment to the client
- Ensures thorough understanding of contracted scope, timeline, and budget for the TMF
- Presents monthly TMF status, risks, issues, and associated action plans to the team
Sr. Project Assistant
ICON Clinical Research
03.2022 - 08.2022
- Created mapping for reconciliation and instructions for Site Lists and Enrollment Logs
- Mentored PA Team new hires
- Maintained Team tracker with all studies and reporting to Sponsors
- Performed all Project Assistant responsibilities
Project Assistant
ICON Clinical Research
06.2020 - 03.2022
- Assisted with the development of project specific Procedure Manuals
- Trained new Project Assistants
- Prepared and distributed Project Reports
- Scheduled site Imaging Manual Training
- Maintained Project Tracking in MIRA for site/subject reconciliation
- Maintained study files including enrollment and end of treatment logs
- Communicated with clients, sites, CRO and CRAs/CRMs
- Assisted with audit preparation
- Maintained and reviewed the eTMF for studies
- Assisted in the development/maintenance of the project specific staffing plan
- Created a workflow for NASH studies
Data Coordinator
ICON Clinical Research
04.2005 - 06.2020
- Processed incoming courier data
- Completed study close-outs. Inventory media and reconcile with electronic system
- Performed a continual quality audit of project documents in the Archive Room and media via MIRA
- Designed a process to ensure physician credentials remain current in the Reader Document
- Conducted Read Monitoring in support of 8 major studies that required escalated timelines
- Performed off-site archive with contract vendor of documents and media to support the event of close-out and non-delivery to client
Education
Some College (No Degree) - Liberal Arts And Sciences
Bucks County Community College
Newtown, PASkills
- Veeva Vault
- Microsoft Office Suite
- DocuSafe
- ICON LS & MIRA
- TransPerfect
Timeline
TMF Lead II
Syneos Health
08.2022 - 03.2026
Sr. Project Assistant
ICON Clinical Research
03.2022 - 08.2022
Project Assistant
ICON Clinical Research
06.2020 - 03.2022
Data Coordinator
ICON Clinical Research
04.2005 - 06.2020
Some College (No Degree) - Liberal Arts And Sciences
Bucks County Community College