Trial Delivery Specialist – Clinical Trial Coordination

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🕒 Junho 30

🌐 México, Brasil, +1 outros países – Remoto

🇲🇽 México – Remoto 🇧🇷 Brasil – Remoto 🇨🇴 Colômbia – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Act as an extension of the client’s global study team to ensure operational perfection in clinical study management across all phases and therapeutic areas. • Ensure the integrity of trial coordination activities - data eTMF oversight ensuring inspection readiness, vendor management, CRO oversight and project planning - while providing guide support that enables efficient, high-quality study delivery throughout the study life cycle.

🎯 Requisitos

• Work as a partner with the global study leader to monitor study conduct and progress – identify, resolve, and advance risks that impact delivery of the study against quality, timeline, and budget objectives. • Work in close partnership with the global study leaders on end-to end operational study delivery activities, from study set up to study archival, with the focus on setting up, maintaining, and ensuring completeness of internal systems/databases/tracking tools and project plans. • Review key clinical documents, including the protocol and informed consent forms, and support the development of study plans including monitoring plans, vendor management plans, protocol deviation management plans, and risk management plans. • Coordinate all study-related activities and handle study cross-functional team’s communication including meetings preparation and scheduling. Facilitate and monitor all communication interactions with internal and external study team members including regulatory, LOC, CROs, and third-party vendor partners to ensure the successful delivery of assigned studies. • Support country oversight activities, acting as a primary point of contact, tracking recruitment progress, data completeness and compliance, local budgets, protocol deviations and import license status. • Responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables. • Oversee delivery of clinical supplies, investigational products (IP) and all study materials provided by external service providers. Alert the study teams to issues or risks to continuity of supplies and recommend proposed actions. • Handle change orders, expenses, and ensuring consistency between systems and agreements, escalating issues to the study stakeholders.

🏖️ Benefícios

• Global exposure: Work on international clinical studies across phases and therapeutic areas, partner with global teams, CROs, vendors, and country operations. • End-to-end ownership: Contribute to every stage of study delivery, from set-up to close-out. • Analytical & project skills: Strengthen global project management, financial tracking, data analysis, and risk management abilities. • Learn new clinical trial technologies like AI platforms to conduct a global clinical trial.