Clinical Site Lead

🔥 17 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $99.6k - $184.2k / year

⏰ Full Time

🟠 Senior

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Novo Nordisk

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1923

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

Novo Nordisk is a global healthcare company that has been at the forefront of research in obesity and diabetes for over 25 years. Their mission is to improve the lives of people suffering from obesity and diabetes through innovative treatments and sustainable practices. With a strong commitment to patient safety, Novo Nordisk actively combats falsified medicines and strives to enhance the integrity of their products. They offer a range of life-saving medications and are dedicated to driving change in the healthcare landscape, ensuring that children and adults alike have access to essential medical care.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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