CTI Clinical Trial and Consulting Services

Lead regulatory start-up strategies for European clinical trials, including the preparation and submission of Part I and Part II applications via CTIS. Coordinate with sponsors, sites, and regulatory bodies to ensure compliance and manage essential study documentation.

The role involves advising project teams on regulatory requirements and managing submissions to IRB/EC and other regulatory bodies. It also includes reviewing study documentation, managing site contracts and budgets, and ensuring compliance with SOPs and country-specific laws.

The role involves planning, implementing, and completing assigned clinical trials, often functioning as a global trial lead, while setting goals and providing leadership to ensure high-quality execution within defined timelines. Responsibilities include overseeing operational aspects for compliance with GCP and regulatory guidelines, managing the full scope of projects from start-up through analysis, and managing budgets and scope changes.

This role involves assisting in the development and management of site budgets and payment schedules for global clinical trials, supporting negotiations, and overseeing study-level and site-level payments for accuracy and timeliness. Responsibilities also include collaborating with Clinical Systems and Finance to manage payment processes, track communications with sites and sponsors, and process invoices and payment requests.