Department: Clinical Trial Operations, International Operations

Location: Vicente López, Buenos Aires. Hybrid working.

Your impact begins here

As Study Start Up Analyst, you will help clinical trials in Argentina get started on time and the right way. You will prepare and submit the documents that Health Authorities and Ethics Committees need to approve a trial. When your work is accurate and fast, sites can start sooner. That keeps research moving for people living with serious chronic diseases.

What You’ll Bring

• A university degree in Life Sciences, Pharmacy or a related field.
• Experience in regulatory work for clinical trials at a CRO or pharmaceutical company, and hands-on experience with ICH GCP
• Experience with trial systems such as CTMS and eTMF
• Knowledge of regulatory submissions: local rules, dossier requirements and clinical trial applications
• Advanced English.
• A sharp eye for detail and the ability to organise and prioritise your work.
• Strong communication skills.
• A team player mindset.

What You’ll Do





You will own start-up and submission activities for your assigned trials, from the first plan to green light – the final approval for a site to start.

• Lead and coordinate the preparation, review and submission of Health Authority and Ethics Committee dossiers for your assigned trials, in line with ICH GCP, local regulations and Novo Nordisk processes
• Co-develop the start-up plan with Trial Managers and the Trial Start-Up Manager, and plan and track regulatory milestones at country and site level
• Adapt, translate and validate key documents – such as informed consent forms, patient materials, labels and clinical trial application documents – including updates requested by authorities
• Drive green light activities: collect essential documents, perform quality control, file in eTMF and keep local trial registries and safety submissions up to date
• Identify site-level and compliance risks early, act to prevent or mitigate them, and

📌 Study Start-Up Analyst (Vicente López)
🏢 Novo Nordisk
📍 Vicente López