Overview
In this role you will drive end-to-end operational delivery of assigned clinical studies, leading cross-functional teams and overseeing CROs and site-facing activities. You will anticipate risks, enable timely decisions, and ensure governance throughout the study lifecycle. You will collaborate across Clinical Operations, Data Management, Regulatory Affairs and Medical Monitoring to maintain quality, timelines, and budget while safeguarding data integrity and patient safety. This is an opportunity to shape trial operations in a global, multi-functional environment at a company focused on innovative therapies.
Retribuzione / Benefits
salary starting from 57,000 EUR
comprehensive remuneration system
local pay transparency
opportunity for professional growth
collaborative work environment
international exposure
Responsabilità
Lead operational delivery and cross-functional coordination across the study lifecycle from protocol to CSR.
Contribute to protocol and study document development (e.g., ICF)
Lead feasibility, country/site strategy, start-up, activation and recruitment performance with internal and external partners
Develop and drive risk-management strategies to identify and resolve bottlenecks
Manage CROs and vendors with sponsor oversight on performance, timelines, quality, KPIs, risks, and escalations
Chair cross-functional Clinical Trial Team meetings and align relevant functions
Serve as primary operational study contact ensuring governance, communication, decisions, escalation




Ensure timely delivery of study documentation (CRFs, DMP, monitoring plans, training plans, data review plans, SAP)
Oversee data review and cleaning with Data Management and Medical; resolve data issues
Maintain TMF quality and inspection readiness; address gaps and escalation
Collaborate with Clinical Trial Supply for product availability and forecasting
Manage and track study budget, forecasting, accruals, change orders, invoices with PM and Finance
Review and approve vendor invoices
Support registration and results disclosure in ClinicalTrials.gov and registries
Lead operational study close-out including TMF closure and CSR input
Contribute to SOPs, templates, and process improvements with QA and other functions
Requisiti fondamentali
6–8 years of clinical research experience in pharma/biotech/CRO
3–4 years direct clinical study management experience
Experience in cross-functional, multicultural, international trials
Proven ability to manage study delivery across quality, compliance, budget and timelines
Experience in CRO and vendor oversight, performance management and issue escalation
Ability to work independently while leading cross-functional teams
Rare disease experience is preferred
Senior operational leadership
Clear and influential communication
Strong organization, prioritization and tracking
Good Clinical Practice knowledge
Clinical trial design and global study delivery
Proficiency with eCRF/EDC, IRT/IXRS, CTMS and eTMF platforms

📌 Clinical Study Manager (Monza)
🏢 EUSA Pharma
📍 Monza