Senior Clinical Trials Manager

Vaga não está no LinkedIn

🕒 Maio 8

🌵 Arizona, District of Columbia, +3 estados a mais – Remoto

🌵 Arizona – Remote 🏛️ District of Columbia – Remote 🏖️ New Jersey – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote

💵 $127.680 - $213.465 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Agilent Technologies

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1999

🔬 Ciência

🧬 Biotecnologia

💊 Farmacêutico

💰 $500.000.000 Post-IPO Debt em 2019-09

Science • Biotechnology • Pharmaceuticals

A Agilent Technologies é líder global no campo de instrumentos analíticos e de laboratório. A empresa oferece um portfólio diversificado de produtos e soluções, incluindo cromatografia gasosa e líquida, espectrometria de massas, suprimentos de laboratório, além de software e soluções de informática. A Agilent atende a diversos setores, como o biofarmacêutico, testes de alimentos e bebidas, diagnóstico clínico e análises ambientais. Além disso, a Agilent oferece serviços abrangentes para gestão de laboratórios, manutenção e reparo de instrumentos. A empresa tem forte foco em avançar a ciência por meio de soluções sustentáveis e em apoiar genômica, patologia e pesquisa em câncer com tecnologias avançadas.

Descrição

• Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. • Support and oversee study-related work of Clinical Research Associates (CRAs) to ensure proper site training and management • Manage study deliverables and track study metrics including identifying potential risks to study timelines and/or conduct • Review, suggest edits and approve monitoring trip reports for studies • Participate in data management activities, such as CRF development, training, and facilitating query resolution • Lead or contribute to organizational and departmental process development, improvement, and implementation • Provide guidance and mentorship to junior team members.

🎯 Requisitos

• Bachelor's degree or higher, or equivalent credentials • Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements • Strong interpersonal skills (verbal and written), organizational, and prioritization skills • Ability to work independently and effectively in a fast-paced environment • Strong work ethic and ability to deliver tasks on time • Proficient with office automation tools, especially Microsoft PowerPoint, Excel and Word. • For Sr CTM: 5+ years of clinical study management experience in sponsor, CRO and/or companion diagnostics, device manufacturer, IVD, or similar industry(ies) demonstrating effective and successful study management from study inception through close-out. • Experience in line management of CRAs and CTMs preferred.

🏖️ Benefícios

• Bonus • Stock options • Health insurance • Paid time off • Remote work options