Global Clinical Trial Operations Intern

About the role

This fixed-term internship is a Global Clinical Trial Operations Internship under the oversight of a line manager, focused on comprehensive trial and site administration. The intern works closely with CRAs and CTCS at local level, and supports site management with the guidance of a Sr. CRA, CRA or CRA Manager.

Key responsibilities

• Trial and site administration, including tracking and reporting documents such as safety reports
• Collating and distributing study tools and documents, updating CTMS and trackers, and managing document flow and archiving (including eTMF)
• Preparing documents and correspondence, assisting with eTMF reconciliation and the Investigator trial file binder
• Meeting planning: creating and tracking study memos, letters and protocols, supporting local investigator meetings and preparing materials and venues
• Creating posters and videos, and improving local processes through automation, coding and AI
• Supporting site readiness and site visits (validation, initiation, monitoring, close-out) and maintaining accurate visit and non-visit reports
• Collecting and reviewing regulatory documentation for study start-up, maintenance and close-out, and keeping CTMS, eTMF and other systems up to date

Required profile

• Fluent in local languages and English (verbal and written), with good communication skills and the ability to understand technical information
• Good understanding of clinical research, phases of clinical trials, GCP/ICH and country clinical research laws and guidelines
• Developing skills in site management, monitoring and independent professional judgment
• Effective time management, organization, conflict management and cultural awareness; able to work in a matrix, multicultural environment

Required skills

• Database management, data entry and document management
• Good IT skills such as automation, video editing, coding and AI

What we offer

• Employee status: Intern/Co-op (fixed term)
• Relocation visa sponsorship
• Flexible work arrangements and hybrid shift