18 ott
|
Evidilya
|
Romano di Lombardia
18 ott
Evidilya
Romano di Lombardia
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.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 onboardingDraw 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 policiesSupport the clinical team in trial monitoring activitiesReview and approve monitoring reports, ensuring prompt resolution of any issuesManage the project budget and cost analyticsRequirementsScientific degree (ICH-GCP and Project Management training are a plus)Excellent communication, organizational, time-management and decision-making skillsNice to have: knowledge of CTMS and EDC softwareWhat we offerRAL range: € 28.000 – 35.000, commensurate with experienceHybrid working model with 9 remote working days per month and xysqume flexible working hoursMeal vouchers (€ 8 per working day) and a company welfare platformA 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 DirectorA small, cross-functional team where your contribution is visible and decisions are fastExposure to diverse study types — observational, pre-clinical and clinical — across Food & Nutrition, Pharma and MedTech, with a strong digital and data-driven approach#J-18808-Ljbffr
📌 Study Project Manager (Romano di Lombardia)
🏢 Evidilya
📍 Romano di Lombardia