Francis R
Clinical Operations Lead / Senior Clinical Trial Manager
- Role
- Senior Clinical Trial Manager at Bristol Myers Squibb
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Francis R
Clinical Operations: Global Phase trial execution, study management, portfolio delivery acrossoncology and rare disease• Drug Development: Protocol design input, feasibility, site selection, start-up, monitoring, database lock,regulatory submissions• Compliance & Quality: ICH-GCP/GVP adherence, risk-based quality management (RBQM), inspectionreadiness, data integrity, balanced risk approach• Collaboration: Matrixed cross-functional teams, distributed-authority environments, advice-seeking culture,\"working out loud\"• Strategic Impact: Outcomes-based work, rapid cycle optimization, high-impact prioritization, continuousimprovement, change management• Site Partnerships: Investigator-centric engagement, preferred partner positioning, enrollment optimization,site retention• Innovation: Digital trial enablement, decentralized models, patient-centric technologies, inclusive researchstrategiesTherapeutic Areas: Oncology (Hematologic Malignancies: AML, BPDCN; Solid Tumors: Breast Cancer, ESR1Mutations; Targeted Biologics: CD123)| Rare Diseases | Lysosomal Storage Disorders | Gene Therapy | Neurology | Cardiovascular
Experience
Senior Clinical Trial Manager
Apr 2024 — Present
Directed Phase registrational oncology trials (CD123-targeted biologics, AML/BPDCN) across 60+ sitesspanning North America, Europe, and Asia, collaborating with Medical, Regulatory, Biostatistics, and DataManagement in distributed-authority model to achieve 100% milestone adherence and deliver mid- and long-term program outcomes on schedule.• Optimized $22M annual clinical operations budget by implementing KPI-driven CRO governance andstrategic vendor negotiations, realizing 10% cost reduction ($2.2M savings) while maintaining 98% eTMFcompleteness and inspection-ready quality standards.• Accelerated study start-up timelines by 15%(reduced from 12 months to 10.2 months average) through tieredfeasibility modeling and investigator-centric site selection that prioritized high-performing sites andeliminated low-value activities via rapid cycle optimization.• Enhanced patient and investigator experience by championing digital trial tools (eConsent, remotemonitoring, patient portals), achieving 40% improvement in patient experience scores and strengthening siteengagement to position BMS as preferred partner in competitive oncology landscape.
Education
University of Port Harcourt
Doctor of Philosophy - PhD, Pharmaceutical Sciences
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