13 set - San Donato
PHIDEALIVE
Quality Assurance (GCP) Specialist
Company Description
Phidealive S.R.L. is an independent Italian full-service Contract Research Organization (CRO) operating as a Clinical Research Atelier.
Unlike large global CROs, we work through a selective, highly tailored model, combining scientific expertise, regulatory rigor and close operational involvement in every project. We partner with pharmaceutical and biotech companies, medical device developers and academic investigators to design and deliver clinical studies in Italy and internationally.
Our multidisciplinary team supports clinical development throughout the study lifecycle, from strategy and protocol design to regulatory activities, study start-up, project management, monitoring, data management, biostatistics and medical writing.
We focus on projects where quality, reliability and scientific value are essential to generating meaningful evidence and advancing healthcare solutions.
Role Description
Phidealive is seeking an experienced Quality Assurance professional with solid and demonstrable expertise in Good Clinical Practice (GCP) and clinical research.
The successful candidate will support the oversight, maintenance and continuous improvement of Phidealive's Quality Management System and ensure that clinical activities are conducted in compliance with applicable regulations, internal procedures and sponsor requirements.
Key responsibilities will include:
- Maintaining and improving the Quality Management System, including SOPs, policies, templates and quality records;
- Planning,conducting and reporting internal audits, vendor audits, investigator site audits and study-specific audits;
- Reviewingclinical trial documentation and processes from a quality and compliance perspective;
- Managing audit findings, deviations, root cause analyses and Corrective and Preventive Actions (CAPAs);
- Supporting inspection readiness;
- Providingquality oversight throughout the clinical study lifecycle;
- Advising Clinical Op
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