Clinical Study Manager
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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
- 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
- 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
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