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.
Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies.
Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group 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
Clinical Trial Application Forms
submission dossier preparation
interaction with Competent Authorities
Ethics Committee submissions
maintenance of project plans
essential document review
Patient Information Sheet customization
Informed Consent Form customization
translation coordination
communication with key functions
site level critical path data
audit/inspection readiness
Nice-to-have
passion for rare diseases
passion for oncology
strong organizational skills
knowledge of local clinical trial laws
Key Requirements
Bachelor’s degree in life sciences or related field