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Senior Start Up Associate - Freelance in Greece

1 month, 2 weeks ago
Greece
Freelance
Senior
Project Coordinator
Project and Program Management
Apply Now
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001
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Description

  • Manage study start-up activities at country and site levels for assigned studies.
  • Prepare, submit, and track initial applications and amendments to Competent Authorities, Ethics Committees, IRBs, and other applicable bodies.
  • Handle official communication with authorities and prepare response packages for queries.
  • Advise study teams on local legislation from a submission perspective and on import/export requirements.
  • Adapt trial materials such as ICFs, labels, and patient documents to meet local country requirements.
  • Compile IP release and essential document packages to support timely site activation.
  • Support contract negotiations with sites and institutions.
  • Manage translation requests and review translated local-language trial documentation for submissions.
  • Keep study management databases updated and file trial correspondence in the TMF according to SOPs and study plans.
  • Provide ongoing status updates to study teams, sites, and the study PM team.

Requirements

  • Bachelor’s degree in Life Sciences, Nursing, or a related field.
  • Fluent English language skills.
  • Minimum 2-3 years of recent hands-on experience with start-up activities in Greece, including submissions under CTR via CTIS.
  • Strong knowledge of clinical research regulatory requirements at country and global levels as per GCP.
  • Experience using Microsoft Office Suite.
  • Strong attention to detail and time-management skills.
  • Ability to work collaboratively within study teams and with clients/vendors as applicable.
  • Experience in a Clinical Operations or Study Start-Up role (preferred).

Interested in this position?

Apply directly on the company website

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