24 set - Belluno
Chiesi
Overview
In this role you coordinate the operational management of assigned clinical projects to advance Chiesi's pipeline in line with medical standards.
You act as the primary liaison to CROs, providers, and internal stakeholders, ensuring study quality, timelines, and budget adherence.
You play a key part in study design input and risk management, supporting the execution and reporting of clinical data.
This position offers exposure to a globally distributed R&D; team and meaningful impact on patient-focused drug development.
Retribuzione / Benefits
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
remote work options
Responsabilità
Manage 1–3 clinical trials depending on size and phase
Oversee Clinical CROs/Providers and serve as primary contact for CROs and internal customers
Ensure adherence to scope, timelines, and budget
Review study documents (project plan, monitoring plan, risk management plan, site contracts) and perform co-monitoring as needed
Contribute to Study Risk Register and lead clinical risk reviews with cross-functional teams
Oversee study eTMF with CTA and coordinate CTS strategy with CTS team
Coordinate preparation of experts/KOL contracts when applicable
Prepare and review CSR with Medical Writer; support external/internal presentation of results
Liaise with CTS for CTS strategy; manage CTS delivery at sites
Ensure SOP compliance and manage CAPA and follow-ups, including audits
Provide clinical operations input during study design and CPAC meetings
Budget preparation and management for ongoing studies
Requisiti fondamentali
At least 3 years in a similar pharmaceutical role
Track record of successful planning and execution of at least 5 clinical studies
Degree in Life Sciences or equivalent
English fluent
Knowledge of clinical study design and biostatistics
Familiar with planning tools and principles
Knowledge of ICH/GCP and company SOPs
Knowledge of GLP for bio-analytical assays (clinical pharmacology)
Up-to-date with relevant literature
Strong communication and stakeholder management
Cross-functional collaboration
Attention to detail and organizational skills
Clinical trial management and CRO oversight
Budget management for clinical studies
Study design principles and statistics
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