Regulatory & Start Up Specialist
Posted on Mar 15, 2019 by IQVIA
This person will manage the Start-up process of clinical studies, being part of a high performing team.
•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
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
Ability to be multi-tasking in a fast-paced environment and to work on a team