Clinical Site Lead

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🕒 Julho 20

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $99.600 - $184.200 / ano

⏰ Tempo Integral

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Novo Nordisk

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1923

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

A Novo Nordisk é uma empresa global de saúde que está na vanguarda da pesquisa em obesidade e diabetes há mais de 25 anos. Sua missão é melhorar a vida das pessoas que sofrem de obesidade e diabetes através de tratamentos inovadores e práticas sustentáveis. Com um forte compromisso com a segurança dos pacientes, a Novo Nordisk combate ativamente medicamentos falsificados e se empenha em aprimorar a integridade de seus produtos. Oferecem uma gama de medicamentos que salvam vidas e estão dedicados a impulsionar mudanças no cenário da saúde, garantindo que crianças e adultos tenham acesso a cuidados médicos essenciais.

Descrição

• Contributes to the successful execution of clinical trials through driving the performance of clinical trial sites with cross-functional coordination and communication for assigned trials • Supports process improvement and innovation projects • Oversees clinical site performance and ensures consistency in site management for assigned trials by providing support and guidance to CRAs and In-House CRAs, including review of monitoring visit reports, site metrics, and data trends to ensure quality and compliance • Coordinates and drives site start-up/activation activities, including the deployment of Site Selection Visit (SSV)/Site Initiation Visit (SIV) training tools and materials • Drives US monitoring activities in accordance with the Monitoring Plan as well as Risk-Based Quality Management (RBQM) principles including coordination of deliverables for database lock (DBL) and site/trial closure • Supports internal audits and health authority inspections in collaboration with the Trial Manager, including inspection readiness activities and the development of corrective/preventative action plans • Develops trial-level site communications inclusive of key updates and information

🎯 Requisitos

• Bachelor's degree or Registered Nurse (RN) degree/diploma required • Minimum of 6 years’ experience in the planning, and conduct of GCP clinical trials, including at least 4 years of direct site management and logistical clinical trial execution in the pharmaceutical industry (Pharma/Biotech/CRO) required • On-site monitoring experience preferred • Strong understanding of International Council for Harmonisation Good Clinical Practice (ICH-GCP) principles and the application of those principles to trial planning and execution required • Excellent communications skills (verbal, written, presentation) in English • Demonstrated collaborative and stakeholder management skills • Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management

🏖️ Benefícios

• medical, dental and vision coverage • life insurance • disability insurance • 401(k) savings plan • flexible spending accounts • employee assistance program • tuition reimbursement program • voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance • sick time policy • flexible vacation policy • parental leave policy