Joyce Lynn Bean
Doylestown,US
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. These experiences have culminated in Joyce being an integral part of the Biopharmaceutical Acceleration Model (BAM), which is shortening the distance from lab to life. Clinical Research Therapeutic Areas to include Cardiology, Oncology, and Contrast Agents in accordance with the work performed by Medical Imaging Service line. Systems/Computer skills include: Veeva Vault, Microsoft Office Products including, Excel, Outlook, PowerPoint, SharePoint, Word, DocuSafe Customer Database, ICON LS, TransPerfect, V e e v a V a u l t, MIRA, Teams
Overview
21
21
years of professional experience
Work History
TMF Lead II
Syneos Health
USA
08.2022 - Current
- Involved in Trusted Process meetings such as Kick-Off Meetings, QuickStart Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject matter Expert (SME) and presents TMF status updates to drive the execution/delivery of the TMF.
- Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME.
- Prepares and participates in project-specific audits/inspections to ensure ongoing readiness of the TMF.
- Facilitates monthly meetings to provide metrics to the Sponsor and Project Team on TMF health/status and completes follow-up on actionable responsibilities. Provides re-training to the Project Team.
- Monitors TMF completeness by initiating Quarterly Completeness Checks and generating TMF completeness reports.
- Works together with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state. Reports on all non-compliance issues.
- Provides timelines to the Project Team and TMF Operations Team for the TMF Shipment, including timelines for final Completeness Checks, document submissions, TMF Export and QC and shipment to the client.
- Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Documents any out-of-scope work and communicates this to the Project lead to add to a Change Notification Form/Change Order.
- Presents monthly TMF status, risks, issues and associated actions for assigned projects during the TMF Project Delivery Health Assessment (PDHA).
- USA Pennsylvania Home Based
Sr. Project Assistant
ICON Clinical Research
Blue Bell, PA
03.2022 - 08.2022
- Create mapping for reconciliation and instructions for Site Lists and Enrollment Log for PA Team.
- Mentor/Assist/Train PA Team new hires and PA Team.
- Maintain Team tracker with all studies and reporting to Sponsors.
- Perform all tasks listed as Project Assistant also.
- Beacon Bioscience, Doylestown PA
Project Assistant
ICON Clinical Research
Lansdale, PA
06.2020 - 03.2022
- Assist with the development of project specific Procedure Manual.
- Training new Project Assistants
- Prepares / distribution of Project Reports weekly to Sponsor.
- Scheduling of site Imaging Manual Training.
- Management of Study Sites for supplies, applicable system access and queries.
- Updates and maintains Project Tracking in MIRA with information including site/contact and site/subject reconciliation feature.
- Updates and maintains study files including enrollment logs and data status.
- Communication with clients, sites, CRO and CRAs/CRMs.
- Assists with audit preparation.
- Maintains the eTMF for studies, reviewing every six months.
- Assist with the development/maintenance of the project specific staffing plan.
- Created a workflow for NASH studies.
Data Coordinator
ICON Clinical Research
Doylestown, PA
04.2005 - 06.2020
- Process incoming courier data. Scan documents to electronic file and assign source media to a serial number. Create shipment in electronic tracking system (MIRA-Medical Imaging Review Analysis). File all study documents and physical media in a secure Archive Room.
- Complete study close-outs. Inventory media and reconcile with electronic system. Quality checks all documents creating a spreadsheet for project team to deliver to the sponsor. Follow a disciplined and organized project management approach to ensure the project meets business objectives and timelines.
- Attend kick-off meetings, monthly team meetings and close-out meetings for all assigned studies.
- Perform a continual quality audit of project documents in the Archive Room and media via MIRA.
- Conduct a monthly Out of Document Control audit of media in the Archive Room ensuring MIRA notes the correct status of all media and outstanding media has physically been returned.
- Designed a process to ensure physician credentials remain current in the Reader Document
- Selected to be trained for 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 or space issues.
Education
Bucks County Community College
Newtown, PATimeline
TMF Lead II
Syneos Health
08.2022 - Current
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
Bucks County Community College