Overview In this role you will lead country-level Site Activation activities for Italy, ensuring regulatory compliance and timely delivery of start-up documents. You will act as a single point of contact for investigative sites, SAMs, and project teams, guiding feasibility and regulatory submissions. You will prepare and review site documents, track approvals, and ensure quality across deliverables. Join a collaborative, compliant team focused on accelerating clinical development for innovative therapies.
Responsibilities Lead complex projects as regulatory/start-up specialist and serve as SPoC for sites and cross-functional teams
Ensure SOPs, WIs, quality of deliverables and timelines are followed
Prepare and submit submission documents to regulatory bodies
Perform feasibility, site ID, startup and activation activities per regulations and SOPs
Prepare site documents, review for completeness/accuracy, and track approvals and document release
Inform team of completion milestones and provide local expertise during timeline planning
Quality control of documents provided by sites




Act as SME on specific subjects, mentor junior CSAs, and sponsor-facing interactions
Responsibilities (Continued) Note: The following section consolidates the Italian language responsibilities into a structured format for clarity and alignment with standard job documentation.
Qualifications BSc in Health Sciences or related field
1 to 3 years' clinical research experience
Experience in EUCTR and CTIS submission procedures; feasibility and Italy ICF adaptation beneficial
Site contract negotiations with Italian sites beneficial
Experience in medical device submissions beneficial
Strong knowledge of clinical systems, procedures, and corporate standards
Good communication in local language
Effective communication, organizational and interpersonal skills
Ability to work independently, prioritize tasks, and manage multiple projects
Knowledge of GCP/ICH and regulatory guidelines; understanding of reg

📌 Country Associate Submissions Representative, Italy, IQVIA Biotech (Italia)
🏢 Altro
📍 Italia