Study Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hre0v

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 Direct

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hre0v