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Site MGMT coordinator 2

IQVIA Holdings Inc.

Budapest, Hungary

Regulatory and Start-up Specialist I or II (Contract Specialist)

IQVIA Hungary is looking for a Regulatory and Start-up Specialist I or II (Contract Specialist) based in Budapest to join our multi-sponsor RSU team. This person will manage the Start-up process of clinical studies, being part of a high performing team.

Main Accountabilities

  • Perform Start-up and Maintenance contracting and budget negotiation activities according to applicable regulations, SOPs and work instructions;
  • Review, prepare and negotiate site contracts and budgets with sites;
  • Ensure contracts are fully executed, site related essential documents and approvals are granted, and specific project deliverables are completed;
  • Review, establish and agree on project planning and project timelines;
  • Oversight assigned projects on country level during the start-up phase;
  • Organize and lead budget kick-off and clinical handover meetings;
  • Cooperate and communicate with the local management, Regulatory Specialist, Centralized RSU, Global Study Team, Lawyer, Contract Template- and Budget Expert, Investigators and other site staff, CRAs;

Requirements

  • BSc/MSc degree
  • Previous experience with contract- and budget negotiation;
  • Professional level of English and Hungarian (written and spoken)
  • Excellent Microsoft Office Skills and communication skills
  • Ability to be multi-tasking in a fast-paced environment

We will offer an initial 12 months fixed term contract with the possibility (and intention) to extend to a permanent contract. The job will be office based in Budapest but we are open to a % of home-working.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Job posted: 1970-01-01

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