Clinical Associate Submissions Representative (Regulatory & Start-Up Specialist)

Homebased
Italy
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.
Job Overview
Position requires EU CTR experience for Italy, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions
As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites,



Site Activation Manager, Project Management team, and other departments as necessary.
You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.
You will prepare submission documents and submit to regulatory bodies.
You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.
You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.
Coupled with informing team members of completion

📌 Clinical Associate Submissions Representative, Italy, IQVIA Biotech (Italia)
🏢 Iqvia
📍 Italia