Senior Start Up Associate - Freelance in Greece

About the role

Biomapas is looking for a freelance Senior Start Up Associate (SSU) to join its Clinical Operations team in Greece, working 0.5 FTE. The SSU manages study start-up activities at country and site levels through the Clinical Trial Registry (CTR) via CTIS for Part 2, in line with other applicable Greek regulatory requirements, and is accountable for the start-up deliverables at country and site level. The position suits an experienced Study Start-up Associate who wants to gain more experience.

Key responsibilities

• Perform and manage start-up activities for assigned studies at country and site levels
• Prepare, submit and track initial applications and amendments to Competent Authorities, Ethics Committees (CA/CEC/LEC) / IRBs and other bodies
• Manage official communication with authorities and ethics committees, preparing response packages to address their queries
• Advise study teams on local legislation from a submission perspective and on import/export requirements
• Adapt trial materials such as ICFs, labels and patient documents to local country requirements
• Compile IP release and essential document packages to ensure timely site activation
• Support contract negotiations (CTAs) with sites and institutions
• Manage translation requests and review of local-language trial documentation
• Keep study management databases updated and file trial correspondence into the TMF according to SOPs and study plans
• Maintain ongoing status updates with study teams, sites and the study project management team

Required profile

• Bachelor's degree in Life Sciences, Nursing or a related field
• Fluent English
• At least 2-3 years of recent hands-on experience with start-up activities in Greece, managing submissions through CTR via CTIS
• Strong knowledge of clinical research regulatory requirements at country and global levels, as per GCP

Required skills

• Experienced user of Microsoft Office Suite
• Attention to detail and time-management skills
• Teamwork and collaboration with study teams, clients and vendors