Senior Clinical Trial Manager, FSP

🕒 6 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟠 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

• Manage clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP • Assume regional Lead CTM, Clinical Study Manager, process improvement, program management, or project coordination responsibilities as assigned • Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans • Set up, organize, maintain, and archive relevant Trial Master File documents and study materials • Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Prepare, organize, and present at client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and other departments, lead team meetings, and maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Communicate with study sites regarding protocols, patient participation, case report forms, and study issues • Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable • Provide input to clinical activity forecasts • Manage clinical resources, delegate responsibilities, and identify additional resource requirements • Conduct accompanied field visits and manage project financials when required • Perform limited line management responsibilities on assigned GPHS projects in North America

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job • An equivalency combining appropriate education, training and/or directly related experience may be considered • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, financial, and attention-to-detail skills • Understanding of change management principles • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Effective oral and written communication skills, including English language proficiency • Knowledge of budgeting, forecasting, and fiscal management • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel, Word, and computerized applications • Ability to independently manage clinical-only studies • Willingness and ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefícios

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused work environment

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