Study Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/861ifa

Evidilya, the dedicated Contract Research Organization of SPRIM Health Group, is a full-service CRO with international expertise in designing and managing observational, pre-clinical and clinical studies in the Food & Nutrition, Pharma and MedTech/Medical Device industries, with a strong technological and digital footprint.
We are looking for a Study Project Manager to join our team in Milan.

Main tasks
• Manage all clinical trial and RWE study activities, planning and prioritizing operational tasks against agreed timelines and coordinating the dedicated study team (Medical Writer, Data Manager, CRA, CTA)
• Act as the main point of contact between the CRO and sponsors (study updates, potential issues, change requests)
• Lead study start-up, including regulatory submissions and approvals, site recruitment and site onboarding
• Draw up and maintain the Trial Master File (TMF) and Trial Center Files (TCFs)
• Provide regular updates to the BU Director / Clinical Operations Leader on study status (vendors, activities, timelines, project plan)
• Ensure TMF/TCF compliance with SOPs,



ICH-GCP and applicable regulations, guiding the clinical team on storage and maintenance policies
• Support the clinical team in trial monitoring activities
• Review and approve monitoring reports, ensuring prompt resolution of any issues
• Manage the project budget and cost analytics

Requirements
• Scientific degree (ICH-GCP and Project Management training are a plus)
• Excellent communication, organizational, time-management and decision-making skills
• Fluent English
• Nice to have: knowledge of CTMS and EDC software

What we offer
• RAL range: € 28.000 – 35.000, commensurate with experience
• Hybrid working model with 9 remote working days per month and flexible working hours
• Meal vouchers (€ 8 per working day) and a company welfare platform
• A structured onboarding and continuous training programme (ICH-GCP, project management, soft skills)
• Real ownership of your studies from start-

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/861ifa