Study Project Manager

2 giorni fa

Milan, Lombardy, Italia Evidilya Tempo pieno

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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

Study Project Manager

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