Senior Clinical Trial Assistant (CTA) – Phase 2 (Sponsor-side)
About the company
We are an innovative, clinical-stage biotech company developing breakthrough treatments in fertility. Following a successful Phase 1 program, we are preparing to initiate two pivotal Phase 2 clinical trials in Germany and the US. Our culture is built on scientific excellence, international collaboration, and an agile approach to drug development.
The role
We are looking for an experienced, highly self-driven Senior Clinical Trial Assistant (CTA) to join our clinical team and provide essential operational support across two ongoing Phase 2 trials, while supporting Phase 1 close-out and archiving. This is a key role in a small, fast-moving biotech environment where you will be expected to operate independently from day one and help ensure clinical processes and systems run smoothly and compliantly.
Key responsibilities
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Provide comprehensive administrative and operational support to a clinical team (internal team plus external consultants)
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Proactively set up, maintain and quality-check the Trial Master File (TMF/eTMF) for two new Phase 2 trials
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Support final Phase 1 close-out and archiving activities
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Coordinate end-to-end document flow (drafting support, version control, review cycles, approvals, signatures and filing)
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Track deadlines, milestones and deliverables; follow up on overdue items and escalate when needed
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Support two Senior Trial Managers with day-to-day execution, meeting preparation, action logs and follow-through
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Help ensure all clinical operations processes follow applicable standards and expectations (incl. ICH-GCP)
Your background
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Minimum 5 years’ experience as a Clinical Trial Assistant (senior level preferred)
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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
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Demonstrated ability to work independently, proactively and with strong ownership in an agile setting
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Deep hands-on experience with TMF/eTMF, QC/completeness, and an “inspection readiness” mindset
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Strong organisational skills, attention to detail, and confident stakeholder management
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Fluent in English, written and spoken
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Bachelor’s/Master’s degree or similar academic background (strongly preferred)
What we offer
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Competitive compensation reflecting seniority and experience
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Significant flexibility, including the option of reduced hours (e.g., 80% / 3-day week) and a flexible remote work policy
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A unique opportunity to join a small, close-knit, international team where your contribution is highly visible
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Work on cutting-edge clinical development in an ambitious biotech environment
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A culture that values stability, long-term collaboration, and retention of top talent
Location
Denmark or Southern Sweden is a plus, but location is secondary for the right candidate.
