Lead Clinical Research Associate

Lead Clinical Research Associate

TFS HealthScience

Copenhagen, Denmark

The Lead CRA is responsible for leading and overseeing monitoring strategy and site management activities across a Phase I and Phase II clinical study, ensuring high quality delivery in line with ICH GCP, protocol requirements, and regulatory expectations.

Key Responsibilities

• Oversee and coordinate monitoring and site management activities across Phase I and Phase II studies
• Lead and support CRAs, providing guidance, training, and quality oversight
• Ensure compliance with ICH GCP, SOPs, and study protocols
• Review and approve monitoring visit reports and ensure follow up on site level issues
• Drive a risk based monitoring approach, focusing on critical data and protocol compliance
• Support development and execution of monitoring plans and site training activities
• Track site performance and escalate risks to the Project Manager as needed

Qualifications

• Bachelor’s Degree in life science, nursing, or equivalent
• Minimum 3 years of experience as CRA with strong onsite monitoring experience
• Previous experience taking on lead or oversight responsibilities is an advantage
• Solid understanding of ICH GCP and clinical trial processes
• Ability to work independently in a fast paced and evolving environment
• Strong communication, organisational, and stakeholder management skills