Lead Study Project Manager – Clinical & RWE

Evidilya; Lombardia; Hybrid; EUR 28,000 - 35,000; Full time

Benefits offered by this job

Meal vouchers

Hybrid work model

Onboarding/training

Job summary

Evidilya, the dedicated Contract Research Organization of SPRIM Health Group, is seeking a Study Project Manager to join our Milan team. You will manage all clinical trial and RWE study activities, coordinate the study team and act as the main point of contact between the CRO and sponsors.

You will lead study start-up, ensure TMF/TCF compliance, monitor progress and budgets, and provide regular updates to the BU Director.

Qualifications

• Scientific degree required; ICH-GCP and project management training are a plus.
• Excellent communication, organizational, time-management and decisional skills.
• Knowledge of CTMS and EDC software is desirable.

Responsibilities

• Coordinate all clinical trial and RWE study activities and manage timelines.
• Act as main contact between the CRO and sponsors.
• Lead study start-up, including regulatory submissions and site onboarding.
• Maintain the TMF and Trial Center Files (TCFs).
• Provide updates to the BU Director / Clinical Operations Leader on study status.
• Ensure TMF/TCF compliance with SOPs, ICH-GCP and applicable regulations.
• Support monitoring activities and review monitoring reports.
• Manage the project budget and cost analytics.

Skills

Project management

ICH-GCP knowledge

CTMS

EDC software

Communication skills

Organizational skills

Time management

Decision making

Education

Scientific degree

Tools

CTMS software

EDC software

Job description

Evidilya, the dedicated Contract Research Organization of SPRIM Health Group, is seeking a Study Project Manager to join our Milan team. You will manage all clinical trial and RWE study activities, coordinate the study team and act as the main point of contact between the CRO and sponsors.

You will lead study start-up, ensure TMF/TCF compliance, monitor progress and budgets, and provide regular updates to the BU Director.