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

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

Lead Clinical Research Associate

Key skills