Study Project Manager

3 giorni fa

Lombardia, Italia Evidilya Tempo pieno 28.000 € - 35.000 € Contratto

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.

  • 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
  • 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-up to close-out, working directly with sponsors and the BU Director
  • A small, cross-functional team where your contribution is visible and decisions are fast
  • Exposure to diverse study types — observational, pre-clinical and clinical — across Food & Nutrition, Pharma and MedTech, with a strong digital and data-driven approach