Rebecca Leigh
Project Manager
Barrington,IL
Summary
Bilingual project manager with experience in molding and medical device clinical research studies. A resourceful and performance-driven individual capable of monitoring the development and implementation of projects, FDA submissions, and specializing in cross-functional communication. Seeking a stimulating and rewarding environment to utilize a blend of skill and passion.
Overview
5
5
years of professional experience
4
4
Certificates
1
1
Language
Work History
Project Manager
Abbott
05.2023 - Current
- Designated as project manager in engineering division for Abbott diagnostic products
- Specialized in managed molding, automation and commodity related projects
- Led projects through feasibility, equipment upgrades, design changes, material changes and obsolesces
- Developed comprehensive project plans with clear timelines, milestones, and budget
- Established effective communication and relationships among team members in multiple countries and US states
- Closely collaborated with senior management to align project priorities and strategic company initiatives
- Utilizing SAP, Ariba and Microsoft Excel to closely manage budgets and calculate gross margin improvements
Project Coordinator II
BioMerieux, Inc
01.2022 - 02.2023
- Positioned as program management representative for Molded Parts and Plastic Engineering team
- Managed 25+ molds in development timelines in MS project and prioritized based on resources and company goals
- Implemented fundamental timeline durations using historical and statistical data for 6 types of plastic-injected molded parts
- Orchestrated weekly company plastic engineering meetings, ensured stakeholders were present as appropriate for agenda items, and reported on new development timelines
- Designed/executed Asana structure for entire program management department, including training and presenting, to track programs and projects.
Clinical Regulatory Affairs Research Associate
BioFire Defense (Subsidiary of Biomerieux)
12.2020 - 1 2022
- Monitored, tracked, and closed out 14 clinical research sites (12 international) while meeting all IRB/IEC and HRPO regulatory requirements
- Organized study paperwork data verification wrote FDA-related submission documents, as well as monitored project progress, and adjusted timelines accordingly
- Wrote and verified documentation for one de novo, three 510(k), and four EUA submissions
- Designed data verification structure and timeline
- Tracked progress and assigned research associates appropriately to tasks accordingly to meet FDA and DOD submission deadlines.
Clinical Regulatory Assistant
BioFire Defense (Subsidiary of Biomerieux)
02.2019 - 12.2020
- Maintained consistent coordination with the clinical research project manager for an IVD medical device clinical trial and supported the consequent de novo and 510(k) submissions
- Ensured seamless day-to-day operations by managing shipments of supplies, instruments, and samples from domestic and international clinical research sites
- Monitored incoming study paperwork and data for 14 clinical site simultaneously, Delivered proactive support regarding the creation and implementation of in-house covid screening testing protocol, while managing and ensuring operator-blinded sample handling.
Education
Bachelor of Science - Biology, Cellular And Molecular
The University of Utah
Salt Lake City, Utah2020
Skills
Microsoft Excel
Microsoft Project
Microsoft Timeline Pro
Asana
SAP
Ariba
Certification
AAMI Design Control Requirements Course
Timeline
Project Manager
Abbott
05.2023 - Current
Project Coordinator II
BioMerieux, Inc
01.2022 - 02.2023
Clinical Regulatory Affairs Research Associate
BioFire Defense (Subsidiary of Biomerieux)
12.2020 - 1 2022
Clinical Regulatory Assistant
BioFire Defense (Subsidiary of Biomerieux)
02.2019 - 12.2020
Bachelor of Science - Biology, Cellular And Molecular
The University of Utah