Clinical Site Lead

Novo Nordisk

Clinical Site Lead overseeing trial site performance and execution at Novo Nordisk. Collaborating across functions to enhance clinical trial efficiency and quality.

Posted 7/20/2026full-timeRemote • New Jersey • 🇺🇸 United StatesSenior💰 $99,600 - $184,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial sites, ensuring compliance with ICH-GCP principles, and driving performance through effective communication and collaboration. Proven ability to oversee trial execution, support process improvements, and manage stakeholder relationships.

Highest-signal resume keywords

GCP Clinical Trials ManagementSite Management ExperienceICH-GCP PrinciplesClinical Trial ExecutionStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PlanningSite Start-Up ActivitiesMonitoring Visit Report ReviewData Trend AnalysisRisk-Based Quality Management

Soft Skills

Excellent Communication SkillsCollaborative SkillsChange Management

Tools & Technologies

Site Selection Visit ToolsSite Initiation Visit Training Materials

Certifications & Qualifications

Bachelor's DegreeRegistered Nurse (RN) Degree/Diploma

Industry Keywords

Pharmaceutical IndustryBiotechCROInternal AuditsHealth Authority Inspections

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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