- Location
- Athens, Attica, Greece · published
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Senior
- Source
- Workable
Description
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Site Monitor II is responsible for making sure clinical trial data is accurate, high-quality, and follows all rules and guidelines (ICH GCP and local laws). Monitoring is done via on-site visits, with some remotely as needed. The role works closely with the Site Manager and other team members to ensure the site follows the study plan and is ready for inspections. It also involves regular contact with local investigators and institutions.
Main Responsibilities:
- Ensures regulatory, ICH-GCP, and protocol compliance. Evaluates site and staff performance, recommends site-specific actions, escalates key issues promptly, and develops action plans. Maintains current knowledge of ICH-GCP, regulations, and company SOPs/processes.
- Checks the site and external facilities, equipment supplies (clinical non-clinical) continue adequate conduct trial with their expiry dates (as applicable).
- Conducts source document review and verification or appropriate site source documents and medical records.
Beyond that, you will also be able to:
- Manage reporting of protocol deviations and appropriate follow up.
- Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Conduct follow up for escalated adverse event monitoring (AEM) report query.
Moreover:
- Per the Clinical Monitoring Plan (CMP) or SMP : Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations.
- For assigned activities : understand project scope, budgets, and timelines, manage site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets.