Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
Job Summary
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies according to local requirements and timelines.
Maintain communication with key functions including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management on project specific status and deliverables.
Matching Summary
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
Skills & Requirements
Must-have
site activation readiness
submission dossier preparation
interaction with Competent Authorities
essential document collection
translation coordination
ICH-GCP principles
Nice-to-have
passion for rare diseases
advanced biomarker analytics
oncology expertise
Key Requirements
Bachelor's degree in life sciences or related field