About this role

TFS HealthScience is a leading global mid size Contract Research Organization CRO that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service FSP solutions.

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.

As part of our SRS FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

This is a freelance contract at approximately 0.3 to 0.5 FTE.

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

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

EU Pay Transparency Denmark

Salary: Competitive salary aligned with the Danish market, plus benefits including pension, healthcare, and flexible working conditions

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full service global CRO, we build solution driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.