REGULATORY & START UP SPECIALIST, Athens, Office-based
IQVIA
Athens, Greece
πριν από 1 ώρα

IQVIA Greece is looking for an RSU Specialist based in Athens to join our sponsor-dedicated RSU team.

This person will manage the Start-up process of clinical studies, being part of a high performing team.

Main Accountabilities

  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions;
  • Prepare site regulatory documents, reviewing for completeness and accuracy interacting with Health Authorities / Central Ethics Committee
  • Review, prepare and negotiate site contracts and budgets;
  • Ensure contracts are fully executed, regulatory documents and approvals are granted, and specific project deliverables are completed;
  • Review, establish and agree on project planning and project timelines;
  • May participate in feasibility and / or site identification activities
  • Requirements

  • MSc degree with strong record of academic achievement, preferably in Scientific / Life Science field (Pharmacy, CTF, Biology, Chemistry etc.)
  • 2+ years of experience as RSU (or CRA) in managing submission of applications, modifications and notifications of Clinical Trials to the Health Authorities and contract negotiations in the Greek market
  • Proficiency both in English (written and spoken) and Greek
  • Excellent Microsoft Office Skills
  • Good communication skills
  • Data accuracy
  • Time management
  • Ability to be multi-tasking in a fast-paced environment and to work on a team
  • For further information, visit the company website www.iqvia.com or follow our LinkedIn page

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