Ora

The role involves coordinating and performing quality control for regulatory submissions and clinical documents within Europe. It includes managing the Clinical Trial Information System (CTIS) and collaborating with project teams to ensure compliance with submission standards.

Responsible for the management, quality, and oversight of the electronic Trial Master File (eTMF) across all phases of clinical trials. This includes performing quality control reviews, training team members as a Veeva Vault Super User, and ensuring inspection readiness for regulatory audits.

The CRA II is responsible for managing clinical site relationships and ensuring study conduct complies with ICH/GCP, sponsor SOPs, and local regulations. Key duties include performing site visits, monitoring data accuracy, and managing regulatory documentation throughout the trial phases.

The CRA II is responsible for managing clinical site relationships and ensuring protocol compliance through remote and on-site monitoring activities. They conduct various site visits, manage regulatory documentation, and collaborate cross-functionally to ensure data accuracy and subject safety.

The Senior CRA is responsible for managing clinical site relationships and ensuring protocol compliance through monitoring activities in accordance with ICH-GCP and regulatory standards. This includes conducting site visits, managing regulatory documentation, and collaborating cross-functionally to ensure data accuracy and subject safety.

Senior Clinical Project Managers drive ophthalmic clinical projects forward using best practices to ensure budgets, timelines, and trial requirements are met, while also supporting junior team members. Responsibilities include managing cross-functional teams, creating detailed project plans, providing weekly budget/progress reviews, and ensuring compliance with all regulations and SOPs.