Key Responsibilities

 1. Study Start-up & Submission ExecutionLead, coordinate and manage execution of start-up activities for assigned trials. Oversee the full set of start-up tasks at country and site level and monitor completion against milestones.Lead, coordinate and manage the preparation, review and submission of documents, following local and EU CTR submission procedures, and ensure dossier completeness and accuracy.Use Authority (HA) and/or Ethics Committee (EC) dossiers, ensuring compliance with ICH GCP regulations, local requirements, and Novo Nordisk processes.Co-develop regulatory strategy and SSU plans for assigned trials with TMs and SSU Manager, in alignment with CDC strategy and industry best practice. Collaborate with TMs and leadership to define timelines, submission approaches, and country-specific considerations.Perform Quality Control (QC) and upload documents to eTMF, ensuring regulatory milestones and timelines are met at country and site leve...