Start Up Associate - Estonia (Freelance)

About the role

Biomapas is looking for an experienced Study Start-up Associate (SSU) to join its Clinical Operations team on a freelance basis, working remotely. The role covers start-up activities for studies at country and site level, using CTR via CTIS for Part 2 and other applicable Estonian regulatory requirements, and is accountable for the start-up deliverables at country and site level.

Key responsibilities

• Perform and manage start-up activities for assigned studies at country and site level
• Prepare, submit and track initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC) / IRBs and other bodies
• Manage communication with those bodies and prepare RFI submission packages to address authority 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 actual experience managing submissions under CTR via CTIS in Estonia
• Strong knowledge of clinical research regulatory requirements at country and global level, as per GCP
• Attention to detail and time-management skills
• Teamwork and collaboration with study teams, clients and vendors

Required skills

• Microsoft Office Suite
• Submission management via CTR and CTIS

Candidates apply through the Biomapas application process by submitting their CV in English.