Study Project Manager (Romano di Lombardia)

Study Project Manager (Romano di Lombardia)

19 ott
|
Evidilya
|
Romano di Lombardia

19 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.

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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 xysqume 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

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📌 Study Project Manager (Romano di Lombardia)
🏢 Evidilya
📍 Romano di Lombardia

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