Study Project Manager

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

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.

Ha le carte in regola per avere successo? Le seguenti informazioni devono essere lette attentamente da tutti i candidati.
We are looking for a Study Project Manager to join our team in Milan.

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- 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

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- 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

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- RAL range: € 28.000 – 35.000, commensurate with experience
- Hybrid working model with 9 remote working days per month and xbvzest flexible working hours
- Meal vouchers (€ 8 per working day) and a company welfare platform
- A structured onboarding and contin

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