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Start Up Associate in Estonia (freelance)

πŸ•’ 2 days ago
Clinical Trial Start-upCTISCTRRegulatory Submissions
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πŸ“œ Description

  • Manage study start-up activities and deliverables at country and site levels.
  • Prepare, submit, and track initial applications and amendments through CTIS and other applicable channels.
  • Communicate with authorities and ethics committees, and prepare responses to their queries.
  • Advise study teams on local regulatory requirements and import/export requirements.
  • Adapt trial materials, coordinate translations, and compile documentation for site activation.
  • Support site contract negotiations, maintain study databases, and file correspondence in the TMF.

πŸ› οΈ 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 Estonia 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.
  • Teamwork and collaboration within study teams as well as Clients/vendors as applicable.
Full job description

Freelance opportunity in Estonia! Interested to join our Clinical Operations team as a Start Up Associate (SSU) with regulatory and start up experience in Estonia for 0.3 FTE?

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 Estonia 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 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 RFIs submissions packages to address authorities 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 documents 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 Estonia 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.
  • Teamwork and collaboration within study teams as well as Clients/vendors as applicable.

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