Eleonore Warren
Summary
Clinical Research Professional with a comprehensive end-to-end perspective on the drug product lifecycle, spanning Large-Scale cGMP Manufacturing, Sponsor-level Clinical Development, and Site-level Trial Execution. Proven leader with a track record of managing direct reports and complex study portfolios (Phase II-IV) across therapeutic areas. Expert in bridging the gap between clinical operations, regulatory compliance, and data integrity to drive study success.
Overview
9
9
years of professional experience
6
6
Certifications
Work History
Clinical Research Coordinator
Capital Cardiology Associates
12.2024 - Current
- Managed a diverse portfolio of 15 concurrent Phase II-IV clinical trials, overseeing the execution of protocols involving Class III medical devices, investigational medicinal products (IMPs), complex surgical procedures, and AI-driven diagnostic software to ensure adherence to GCP and FDA/ICH guidelines.
- Maintained inspection-ready Trial Master Files (TMF) and electronic Case Report Forms (eCRF) for high-volume cardiology studies, achieving a <5% query rate and consistently meeting enrollment milestones while facilitating seamless site initiation and monitoring visits for Sponsor representatives.
- Directed end-to-end study start-up and operational workflows for cutting-edge trials, serving as the primary liaison between Principal Investigators, IRBs, Vendors, and Sponsors to streamline patient recruitment strategies and optimize site-level data collection efficiency.
Clinical Development Associate
Xenon Pharmaceuticals Inc.
05.2023 - 09.2024
- Directed cross-functional study teams and vendor partnerships (CROs) to optimize trial workflows, resulting in an overall improvement in regulatory compliance and data management efficiency through the implementation of standardized communication protocols.
- Oversaw study progress and site compliance for epilepsy clinical programs, proactively identifying protocol deviations and conducting rigorous data reviews to ensure 100% alignment with GCP, FDA regulations, and internal SOPs.
- Spearheaded the development and quality-review of critical study deliverables, including Clinical Study Reports (CSRs), TMF documents, and statistical procedure manuals, ensuring streamlined operations and the timely lock of high-integrity clinical databases.
Biotech Production Specialist (Assoc-Lead)
Regeneron Pharmaceuticals Inc.
08.2020 - 08.2022
- Advanced through progressively senior roles to Lead Specialist, providing direct leadership and performance management for a production team in a high-volume, large-scale drug substance manufacturing environment.
- Cultivated a "Quality-First" mindset by managing root-cause investigations (CAPA) and serving as a Subject Matter Expert (SME) during regulatory audits, ensuring the high-integrity production of biologic therapies.
- Established a foundational expertise in cGMP and drug lifecycle management, providing a unique technical advantage in understanding the biochemical constraints and regulatory hurdles of investigational products.
Technical Resources Intern
Regeneron Pharmaceuticals Inc.
05.2019 - 02.2020
- Led a cross-departmental initiative to master and document assay processes in the quality control technical resources lab, enhancing procedural compliance and reducing assay transfer deviance.
- This effort included creating assay-specific PowerPoints and a global method comparison smart sheet, directly contributing to improved GCP adherence.
- Developed and disseminated educational videos on QC assays, capturing critical steps and lessons learned, which served as an essential resource for ongoing training and quality assurance across departments.
Microbiology Lab Intern
Regeneron Pharmaceuticals Inc.
05.2017 - 08.2017
- Led an independent research study on microbiology laboratory cleaning procedures, employing techniques such as gram staining and media growth promotion, which enhanced laboratory compliance with regulatory standards.
- Documented comprehensive data and findings, establishing a robust evidence base contributing to the company's adherence to regulatory requirements and inspection readiness.
Education
Master of Science - Public Health
SUNY University At Buffalo
05-2026
Bachelor of Science - Public Health
SUNY University at Buffalo
05-2020
Skills
- Clinical Trial Oversight (Phase II-IV)
- Cross-Functional Leadership
- ICH-GCP & Regulatory Affairs
- Vendor & CRO Management
- Trial Master File (TMF) & eCRF
- Data Integrity & EDC Systems
- Site & Monitor Readiness
- Clinical Product Lifecycle
- Risk Mitigation & Strategic Planning
- Therapeutic Areas: Cardiology (IMP, Devices/AI), CNS (Epilepsy/Neuroscience), Biologics
- Systems: EDC (Medidata, Veeva Vault, etc), IRT, CTMS, eTMF, eReg, Microsoft Office Suite
Certification
Certified Clinical Research Professional (CCRP) Certification
Languages
French
Native/ Bilingual
Timeline
Clinical Research Coordinator
Capital Cardiology Associates
12.2024 - Current
Clinical Development Associate
Xenon Pharmaceuticals Inc.
05.2023 - 09.2024
Biotech Production Specialist (Assoc-Lead)
Regeneron Pharmaceuticals Inc.
08.2020 - 08.2022
Technical Resources Intern
Regeneron Pharmaceuticals Inc.
05.2019 - 02.2020
Microbiology Lab Intern
Regeneron Pharmaceuticals Inc.
05.2017 - 08.2017
Master of Science - Public Health
SUNY University At Buffalo
Bachelor of Science - Public Health
SUNY University at Buffalo