10 ago
|
Experteer Italy
|
Italia
10 ago
Experteer Italy
Italia
Experteer Overview In this role you will oversee clinical trial sites to ensure protocol adherence, data integrity, and patient safety. You'll drive study quality through risk-based monitoring and collaborate with cross-functional teams to execute trials. You will build strong site partnerships, lead training, and manage study materials and essential documents. This position sits within the Global Trial Portfolio, contributing to transformative therapies for chronic diseases in Italy. Retribuzione / Benefits Act as Site Manager, fostering investigator relationships and ensuring high-quality trial execution across the study lifecycle Conduct on-site and remote visits (selection, initiation, monitoring, close-out) per Monitoring Plan, Protocol, ICH-GCP, SOPs and regulations Lead implementation of RBQM to proactively identify, assess, and mitigate risks during study conduct Oversee site performance, recruitment, retention and data collection to meet timelines and quality goals Lead site training and provide ongoing support on protocols, systems, and compliance Manage IMP, study supplies,
essential documents and Investigator Trial Master File to ensure accountability and compliance Responsabilità Bachelor in Life Sciences Minimum 3 years of clinical trial monitoring experience in pharma or CRO Proven independence in monitoring activities and strong ICH-GCP E6(R3) knowledge GCP certification (valid) Knowledge of electronic CLinical Trial Systems (CTMS, EDC, IWRS, e TMF) Digital mindset with willingness to use AI tools to improve monitoring and data quality Excellent stakeholder management, communication and negotiation skills Strong organizational and time management, problem-solving and risk mitigation Fluency in Italian and English; travel monthly Requisiti fondamentali continuous learning career development benefits tailored to life stage incentives based on position and market benchmarksremote/flexible work arrangements (where applicable) salary within defined range
📌 Clinical research associate ii (Italia)
🏢 Experteer Italy
📍 Italia