Senior Start Up Associate - Freelance in Greece

GreeceRemotePart-timesenior

OtherAssociate

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Key Responsibilities

Perform and manage start-up a activities for the assigned studies at country and site levels. Prepare, submit,

Requirements Summary

Perform and manage start-up a activities for the assigned studies at country an

Technical Tools

OtherAssociate

~1 min read

→Perform and manage start-up a 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.

~1 min read

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