Senior Clinical Trial Administrator

Axcellant; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Flexible working model

Job summary

Axcellant, a boutique CRO in Poland, seeks a Senior Clinical Trial Administrator to support the full lifecycle of clinical studies, ensuring regulatory compliance and high-quality documentation. You will collaborate with Clinical Research Associates, Clinical Project Managers, Sponsors, and investigative sites, handling TMF, site coordination, and translations between Polish and English.

This role offers a lean, ownership-driven environment with a flexible working model and exposure to

Qualifications

• 3+ years of experience as a Clinical Trial Administrator or similar in CRO/pharma
• Strong knowledge of ICH-GCP and TMF management
• Experience supporting trials across phases and working with sponsors

Responsibilities

• Support CRAs and Clinical Project Managers in trial activities
• Maintain Trial Master File and Investigator Site Files per regulatory requirements
• Coordinate site initiation and activation processes; support monitoring and oversight
• Translate between Polish and English for study docs and communications
• Provide general administrative and operational support for trial execution

Skills

ICH-GCP

TMF management

Clinical documentation

Cross-functional collaboration

English-Polish communication

Job description

Location: Poland | Remote / Field-Based / Hybrid

Employment type: Full-time

Reports to: Clinical Project Manager

About Axcellant

Axcellant is a boutique Clinical Research Organization supporting pharma, biotech, and innovative sponsors in the execution of complex, high-impact clinical trials—including oncology, rare diseases, radiopharmaceuticals, advanced diagnostics, and other demanding study designs.

We combine senior-level involvement, operational agility, and scientific depth with a pragmatic, partner-driven approach. As we scale our commercial footprint in Europe and beyond, we are looking for a Business Development Manager who can help shape our growth trajectory—not just execute a sales plan.

This role is ideal for someone who thrives in lean, high-ownership environments, understands how sponsors buy CRO services, and is motivated by building something meaningful rather than selling at scale.

The Role

As Senior CTA, you will provide operational and administrative support across the full lifecycle of clinical trials. You will work closely with Clinical Research Associates, Clinical Project Managers, Sponsors, and investigative sites to ensure smooth study execution, high-quality documentation, and compliance with regulatory requirements.This is a broad and hands-on role, combining clinical trial administration, site coordination, and elements of business support in a dynamic CRO environment.

Key Responsibilities

• Support Clinical Research Associates and Clinical Project Managers in the execution of trial-related activities
• Review, verify, and maintain clinical trial documentation to ensure accuracy, completeness, and compliance
• Create, maintain, and oversee Trial Master File and Investigator Site Files in line with regulatory requirements
• Manage TMF documentation, including filing, tracking, and archiving, ensuring inspection readiness
• Coordinate communication with Principal Investigators and site teams to support study execution
• Prepare sites for Site Initiation Visis and support site activation processes
• Participate in co-monitoring visits to support study oversight and compliance
• Collaborate with Sponsors to ensure alignment on study requirements and expectations
• Support preparation and submission of documents to Competent Authorities and Ethics Committees
• Perform translations between Polish and English to support study documentation and communication
• Support patient recruitment initiatives and site engagement activities
• Provide general administrative and operational support related to clinical trial execution

What We’re Looking For

• Minimum 3 years of experience as a Clinical Trial Administrator or in a similar role within a CRO or pharmaceutical company
• Strong understanding of ICH-GCP, TMF management, and clinical trial documentation
• Experience supporting clinical trials across different phases or therapeutic areas
• Experience working with sponsors and cross-functional clinical teams
• Excellent organizational skills and attention to detail
• Ability to manage multiple tasks and priorities independently
• Strong communication skills in English and Polish
• Proactive, solution-oriented mindset and strong sense of ownership

What We Offer

• An opportunity to work on complex, high-impact clinical trials in a boutique CRO setting where expertise matters
• Direct collaboration with senior clinical leaders and sponsors
• High level of trust, autonomy, and operational ownership
• Exposure to scientifically demanding studies, including innovative therapies and medical technologies
• Competitive compensation and a flexible working model
• A role where your local expertise has visible impact on study quality and delivery