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 team