Clinical Project Manager-Maternity Cover
Core
Coordinate operational management of clinical studies to develop compounds in line with Chiesi's goals and medical/scientific standards.
Role type
Clinical Project Manager
Builds
Clinical studies for Chiesi Farmaceutici
Domain
Pharmaceutical industry, clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, SOP development, CRO/Provider selection, clinical risk management, study registry registration, clinical trial supply management, eTMF management, budget reconciliation, Clinical Study Report preparation
Preferred skills
Centralized systems implementation, respiratory therapeutic area experience
Technologies
clinicaltrial.gov, European registry, eTMF
Responsibilities
Develop full synopsis and protocol based on Study Outline; Collaborate on CRO/Provider selection and RFP implementation; Manage clinical CRO/Providers as primary contact; Set up and maintain Study Risk Register; Coordinate scientific meetings and study result presentations; Ensure study registration in public registries; Liaise with Clinical Trial Supply coordinator; Manage study eTMF and related activities; Account for overall completeness of study eTMF; Manage study budget and reconciliation; Prepare Clinical Study Report (CSR) and coordinate reviews.
Seniority
Mid-level, hands-on IC
