Trial Delivery Specialist – Clinical Trial Coordinator

🕒 Setembro 17

🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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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

• Coordinate, oversee and complete assigned trial activities according to the task matrix • Perform department, internal, country and investigator file reviews and document findings • Ensure allocated tasks are completed on time, within budget and to a high-quality standard • Communicate project risks to project leads and line manager • Maintain study-specific documentation, team lists, training trackers, system access management and project activity plans • Keep the electronic Trial Master File (eTMF) up to date and document review findings • Provide system support, including GoBalto and eTMF • Support risk-based monitoring (RBM) activities • Process documents for the client eTMF, perform eTMF reviews, mass mailings and communications, and provide reports to internal team members • Schedule and organize client/internal meetings and complete meeting minutes • Review and track local regulatory documents • Transmit documents to the client and centralized IRB/IEC • Analyze and reconcile study metrics and findings reports • Assist with clarification and resolution of site-documentation findings • Maintain vendor trackers • Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites • Assist with study-specific translation materials and translation quality control • Attend kick-off meetings and take notes when required • Act as a cross-functional liaison and potential study lead • Support onboarding as a buddy and train new staff as needed • Support departmental and cross-functional process-improvement initiatives

🎯 Requisitos

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • At least 4 years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Ability to work in a team or independently • Strong organizational skills and attention to detail • Proven ability to handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility and adaptability to reprioritize workload • Knowledge of applicable Country Regulations, ICH Good Clinical Practices, organization/Client SOPs and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn clinical trial database systems • Ability to successfully complete the PPD clinical training program • Self-motivated, positive attitude and strong interpersonal skills

🏖️ Benefícios

• Fully remote work arrangement • Standard Monday–Friday work schedule