Senior Clinical Trial Associate

Senior Clinical Trial Associate

TFS HealthScience

Copenhagen, Denmark

The Senior Clinical Trial Associate is responsible for coordinating and maintaining study documentation and supporting clinical trial operations to ensure compliance with ICH GCP, SOPs, and regulatory requirements. You will play a key role in supporting the study team across all phases of the trial, from start-up through close-out.

Key Responsibilities

• Set up, maintain, and close the Study Master File, ensuring completeness and compliance with GCP requirements
• Maintain and update study information in CTMS in collaboration with CRAs and Project Manager
• Support study start-up, maintenance, and close-out activities across sites and countries
• Assist with preparation and coordination of regulatory submissions, amendments, and essential documents
• Act as point of contact for study documentation and support audit and inspection readiness
• Organize internal and external meetings, including preparation of materials and meeting minutes
• Support contract tracking and investigator payments in collaboration with study team
• Assist with preparation of study reports, presentations, and newsletters
• Contribute to process improvements and support onboarding or mentoring of junior team members when applicable

Qualifications

• Bachelor’s degree in life sciences or related field preferred
• Minimum 3 years of experience as a Clinical Trial Associate
• Strong knowledge of ICH GCP and clinical trial processes
• Experience with CTMS and Trial Master File management
• Experience supporting regulatory submissions and study documentation
• Ability to work independently and collaboratively in a matrix environment
• Comfortable working in a fast-paced setting with changing priorities