Regulatory and Site Start Up Specialist

About the role

Handle regulatory and site start-up work for clinical trials, from submissions to authorities and ethics committees to site activation readiness. The role supports study teams and sites so trials can begin on time and in line with regulations.

What you will do

• Ensure sites are ready to activate on schedule and in good quality, anticipating and reducing risks
• Prepare trial application forms and submission dossiers for authorities, ethics committees and local bodies
• Liaise with authorities and ethics committees and manage their responses
• Report submission progress to start-up and regulatory leads and to project teams
• Keep project plans, trackers and regulatory intelligence tools current
• Collect and review essential documents and customise patient information and consent forms

What they look for

• Proven experience in regulatory and site start-up activities for clinical trials
• Knowledge of ICH-GCP and local and international trial regulations
• Ability to prepare submissions within required timelines and obtain approvals
• Skill in coordinating translations and managing document collection
• Strong communication with cross-functional teams such as feasibility, clinical operations and contracts