Regulatory & Start Up Specialist, 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 preferably in Scientific/Life Science field (Pharmacy, CTF, Biology, Chemistry etc.);
• Previous experience in Clinical research;
• Previous experience with contract- and budget negotiation;
• Professional level of English (written and spoken)
• Fluent Hungarian speaker;
• Excellent Microsoft Office Skills;
• Good communication skills;
• Ability to be multi-tasking in a fast-paced environment;

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.