Senior Clinical Project Manager
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
Offerta di lavoro pubblicata 1 giorno fa
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