Senior Start Up Associate - Freelance in Greece

Interested to join our Clinical Operations team as a Senior Start Up Associate (SSU) with regulatory and start up experience in Greece for 0.5 FTE. Senior Start Up Associate is responsible for managing study start-up activities at country and sites' levels under CTR via CTIS for Part 2 and as per other applicable country regulatory requirements and is accountable for the start-up country and site levels study start-up deliverables. This is a position for the experienced Study Start-up Associate (SUA) in Greece within Biomapas Clinical Operations team. Submit your CV in the English language for consideration.

Responsibilities

Perform and manage start-up activities for the assigned studies at country and site levels; Prepare, submit, and track initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC) / IRBs and other bodies if applicable; Manage official communication with Competent Authorities and Ethics Committees (CA/CEC/LEC) /IRBs and other bodies if applicable, prepare response submission packages to address authority queries; Advise study teams on local legislation from submission perspective, on import/export requirements; Adapt trial materials (ICFs, labels, patient documents etc.) to meet local country requirements; Compile IP release/Essential document packages to ensure timely sites activation; Support contract negotiations (CTAs) with sites/institutions; Manage translation request and translations review of required for submissions local-language trial documentation; Keep study management databases updated and file trial correspondence into the TMF as per SOPs and study plans; Maintain ongoing status updates with study teams, sites, study PM team

Requirements

Bachelor's degree in Life Sciences, Nursing, or related field; Fluent English language; Minimum 2-3 years of recent actual experience with Start up activities in Greece managing submission under CTR via CTIS; Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP; Experienced user of Microsoft Office Suite; Attention to detail and time-management skills; Team work and collaboration within study teams as well as Clients/vendors as applicable