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Open nowPosted 45 days ago

Senior Start Up Associate - Freelance in Greece

Workable (global search)108,016 open roles

Where
Greece
Work mode
Remote
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Your applicationOpen nowSenior Start Up Associate - Freelance in GreeceWorkable (global search) · Greece

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The clock on this job

Early applications get read.

7.9% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 7 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 7.9%7 days
  4. 14.9%14 days
  5. 34.0%30 days
This job: posted 45 days ago

Workable (global search) median: 7 days open

The posting

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
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