Senior Clinical Trial Assistant

• Provide comprehensive administrative and operational support to a clinical team (internal team plus external consultants)
• Proactively set up, maintain and quality-check the Trial Master File (TMF/eTMF) for two new Phase 2 trials
• Support final Phase 1 close-out and archiving activities
• Coordinate end-to-end document flow (drafting support, version control, review cycles, approvals, signatures and filing)
• Track deadlines, milestones and deliverables
• follow up on overdue items and escalate when needed
• Support two Senior Trial Managers with day-to-day execution, meeting preparation, action logs and follow-through
• Help ensure all clinical operations processes follow applicable standards and expectations (incl. ICH-GCP)

• Minimum 5 years’ experience as a Clinical Trial Assistant (senior level preferred)
• Strong experience in biotech/pharma on the Sponsor side
• CRO experience may also be suitable if you have clear sponsor-oversight exposure and strong TMF responsibility
• Demonstrated ability to work independently, proactively and with strong ownership in an agile setting
• Deep hands-on experience with TMF/eTMF, QC/completeness, and an “inspection readiness” mindset
• Strong organisational skills, attention to detail, and confident stakeholder management
• Fluent in English, written and spoken
• Bachelor’s/Master’s degree or similar academic background (strongly preferred)

Denmark or Southern Sweden is a plus

• Competitive compensation reflecting seniority and experience
• Significant flexibility, including the option of reduced hours (e.g., 80% / 3-day week) and a flexible remote work policy
• A unique opportunity to join a small, close-knit, international team where your contribution is highly visible
• Work on cutting-edge clinical development in an ambitious biotech environment
• A culture that values stability, long-term collaboration, and retention of top talent