Senior Clinical Trial Operations Lead (Hybrid/Remote)

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

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