Regulatory & Start Up Specialist

Posted on Mar 15, 2019 by IQVIA

Not Specified Italy
Research & Development
13 Mar 2019
Annual Salary
Full-Time
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

Reference: 671078576

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