Amanda M.
Global Pta Program Manager @Thermo Fisher Scientific
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WORK HISTORY
Global Pta Program Manager @Thermo Fisher Scientific
Takeda embedded Global PTA Program Manager
EDUCATION
Temple University
Bachelor of Arts (B.A.), Human Biology
ABOUT AMANDA M.
Exploring New Opportunities in Global Clinical Research Project ManagementStrategic and collaborative clinical operations leader with over 24 years in global clinical research and 17+ years in project and program management. Proven in leading high-performing cross-functional teams, including direct line management of CTMs, CRAs, and CTAs/PMS, with a strong focus on complex global programs. Skilled in site operations and startup execution across NA, APAC, LATAM, EMEA, and MENA, including regulatory strategy, risk-based oversight, and vendor performance lifecycle management. Led governance forums, resolved escalations, and aligned site-level delivery in both traditional and decentralized trial models. Experienced with inspection readiness and fostering team development while ensuring compliance with global regulatory standards (FDA, EMA, PMDA LATAM, ICH-GCP). I’ve successfully executed global submissions, vendor oversight, site management, budget and resource planning, and risk mitigation across NA, EMEA, APAC, LATAM, MENA, and Emerging Markets by bringing many commands and devices to market. My therapeutic expertise spans Oncology, Neuroscience, Rare Disease, Obesity, Immunology, Autoimmune, and other high-impact indications, with a focus on quality, operational integrity, and global regulatory alignment (FDA, EMEA, APAC, LATAM, PMDA, ICH-GCP). Comprehensive knowledge and adherence to ICH/GCP guidelines and SOPs. Recent certifications have been added to my profile.I am excited about advancing clinical research through strategic innovation and operational excellence. If you’re hiring or aware of relevant opportunities, let’s connect! Core Strengths & Areas of Expertise Global Clinical Project & Program Management Regulatory Strategy & Global Submissions (FDA, EMEA, PMDA, LATAM, APAC, MENA and emerging markets) Full Trial Lifecycle Oversight (Start-Up Through Close-Out) Quality, Risk, and Compliance Leadership Financial Planning, Forecasting & Resource Optimization Vendor Oversight Site Oversight Cross-Functional Team Leadership & MentorshipDirect reports/People LeaderEarly, late, and Noninterventional Phase clinical trial delivery Clinical trial diversity practices
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