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.

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
• Originally posted on Himalayas