Senior Clinical Project Manager

Experteer Italy; Emilia-Romagna; Ibrido; EUR 75.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Relocation support

Remote work options

Descrizione del lavoro

Chiesi is seeking an experienced clinical operations professional to coordinate the operational management of assigned clinical projects. You will liaise with CROs, providers, and internal stakeholders to ensure study quality, timelines, and budget adherence, while contributing to study design input and risk management.

You will support execution and reporting of clinical data, oversee eTMF coordination, and drive CAPA processes, audits, and CTS strategy with cross-functional teams across a

Competenze

• Minimum 3 years in a pharmaceutical role.
• Track record of planning and executing at least 5 clinical studies.
• Knowledge of clinical study design and biostatistics.

Mansioni

• Coordinate operational management of assigned clinical projects.
• Liaise with CROs, providers, and internal stakeholders to ensure quality, timelines and budget.
• Review study documents and perform co-monitoring as needed.
• Contribute to study risk registers and lead cross-functional risk reviews.
• Oversee CTS/CTS strategy coordination with CTS team and ensure SOP compliance.

Conoscenze

Clinical operations

Risk management

Biostatistics

ICH/GCP knowledge

Planning tools

Formazione

Life Sciences degree

Descrizione del lavoro

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.

• pension
• private medical insurance
• relocation support
• remote work options
• 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
• 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
• 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)