Haley Fuller

Senior Clinical and Regulatory Affairs Scientist

Role: Senior Clinical and Regulatory Affairs Scientist at Clinical Research Strategies, Llc
Location: Pittsburgh, PA, US
LinkedIn followers: 500 followers

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Experience

Senior Clinical and Regulatory Affairs Scientist
Clinical Research Strategies, Llc
Feb 2025 — Present

Education

University of Pittsburgh
Doctor of Philosophy - PhD
2018 — 2022
Universidad Politécnica de Madrid
Biological/Biosystems Engineering
2014 — 2014
Virginia Polytechnic Institute and State University
Bachelor of Science (B.S.)
2011 — 2015

Contact information

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Work email
•••••@clinicalresearchstrategies.com
Personal email
•••••@•••••.com
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Current company

Clinical Research Strategies, Llc

Biotechnology Research · 12 employees · Wexford, Pennsylvania, United States

Pittsburgh’s Premier Boutique Start-up CRO Partner | Clinical Research and Regulatory Strategy Management | CRO Due Diligence and Management | Trial Rescue | Executive Management Consultancy for Life Sciences Assist new companies and life science/healthcare IT entrepreneurs with corporate start-up. Distill the complexities of regulatory and research disciplines into accessible terms for life science executives, entrepreneurs, and investors alike, who play a pivotal role in the development and investment of a new product, to improve its chances of clearing performance hurdles toward successful commercialization or exit. Customize materials and presentations that offer a fundamental understanding of research from clinical study protocol development with statistical approach, costing and budgeting, site selection, study management, patient recruitment and outcomes, regulatory strategy, approvals, and reporting, risk management, reimbursement, publication, market adoption, and change to clinical practice guidelines. Specialties: corporation start-up and compliance, risk mitigation and assessments, clinical trial performance, CRO due diligence/selection/management, eTMF management and inspection-readiness, QA/audit for inspection-readiness; regulatory pathways, and ROI; assistance with due diligence; and, turnaround clinical trials and partnerships.

clinicalresearchstrategies.com

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Experience

Senior Clinical and Regulatory Affairs Scientist

Education

University of Pittsburgh

Universidad Politécnica de Madrid

Virginia Polytechnic Institute and State University

Find verified contacts for anyone on LinkedIn