Regulatory and Start-Up Specialist

IQVIA Published: November 9, 2020
Location
Milan, Italy
Job Type

Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

IQVIA Italia is looking for an RSU Specialist based in Milan 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 Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions

•Prepare site regulatory documents, reviewing for completeness and accuracy.

•Review, prepare and negotiate site contracts and budgets with sites.

•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 in the submission of applications, modifications and notifications of Clinical Trials to the Health Authorities and contract negotiations
  • Proficiency both in English (written and spoken) and Italian
  • 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

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

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