Senior Clinical Project Manager

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 e

TMF 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