Senior Start Up Associate - Freelance in Greece

Freelance opportunity 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 .  

You have energy and motivation to work in a highly motivated and dedicated CO and SSU teams and to gain more experience?

Submit your CV in the English language for consideration.

Responsibilities:
- 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.