Matthew B.
Clinical Operations Director @ ONCOtherapeutics | Clinical Research, Clinical Operations
- Role
- Director Clinical Operations at Oncotherapeutics
- Location
- West Hollywood, CA, US
- LinkedIn followers
- 500 followers
About Matthew B.
Results-driven Clinical Research Leader with over 15 years of global experience in…
Experience
Director Clinical Operations
Jun 2023 — Present · West Hollywood, CA, US
Led clinical operations for a global portfolio of Phase oncology and medical device studies, implementing new EDC and CTMS systems to enhance trial efficiency and data management. Successfully launched three new oncology studies and multiple medical device trials, expanding the company’s research capabilities and supporting the development of innovative treatment technologies. Additionally, I established a database of 400 regional oncology and medical device research sites, streamlining site selection, feasibility assessments, and investigator engagement to accelerate study startup and execution. Provided strategic oversight of a global portfolio of Phase oncology clinical studies, securing $8M+ in additional contracts by delivering exceptional clinical trial execution. Ensured data accuracy, integrity, and compliance by overseeing clinical data monitoring processes, including source data verification (SDV), discrepancy resolution, and risk-based monitoring (RBM). Collaborated with site teams and data management to ensure real-time data cleaning, regulatory adherence, and audit readiness across global clinical trials. Monitored vendor performance, ensuring deliverables remained on track and within budget, and resolved issues to minimize trial delays. Managed regulatory interactions with FDA and EU authorities, supporting submissions from IND/IDE through validation, resulting in expedited approvals. Collaborate with Project Managers to maintain comprehensive study-specific plans (e.g, Monitoring, Recruitment, Risk Assessment), resulting in a 40% faster issue resolution through enhanced communication strategies. Facilitated cross-functional collaboration through weekly core team meetings, mitigating project risks early and strengthening stakeholder alignment. Introduced large-scale change initiatives to standardize site activation workflows, reducing site start-up times by 20% and ensuring inspection-ready TMFs via periodic quality reviews.
Education
University of Utah
Bachelor of Science - BS
Western Wyoming Community College
Associate's degree
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