Study Start-Up Analyst

Clinical Operations

Buenos Aires Argentina

Be the catalyst that brings clinical trials to life. Navigate regulatory complexities partner with health authorities and ethics committees and ensure studies launch successfully.

Your new role

As a Study Start-Up Analyst youll own the end-to-end execution of study start-up and submission activities for assigned clinical trials. Youll be the regulatory expert who ensures everything is in place for trials to launch on time and in full compliance.

Your responsibilities will include:

• Leading the preparation review and submission of Health Authority (HA) and Ethics Committee (EC) dossiers ensuring compliance with ICH GCP regulations and local requirements
• Obtaining regulatory documentation and requirements to initiate studiesnavigating ethics committee requirements submitting to authorities and strategically managing objections
• Driving internal approvals for labels and documents including the customization translation and validation of Informed Consent Forms and Clinical Trial Application documents
• Developing regulatory strategies and study start-up plans that align with local and global best practices
• Building strong working relationships with clinical sites Ethics Committees and Health Authorities to facilitate smooth submissions
• Managing regulatory milestones in CTMS and executing Green Light activities to keep trials on track
• Ensuring quality through meticulous document control uploading to eTMF and meeting critical timelines
• Submitting safety information to Health Authorities according to local regulations

Your new department

Within Clinical Operations youll join a dynamic Study Start-Up team that sits at the critical juncture between trial design and execution. Your work will enable trials to launch collaborating with global project teams and local stakeholders to turn research plans into reality.

Your skills & qualifications

Were looking for a clinical regulatory professional who combines technical expertise with strong stakeholder management and a solutions-oriented mindset. Youll need:

• A university degree in Life Sciences Pharmacy or a related field (required); an advanced degree is preferred
• Demonstrated experience in clinical researchthis is absolutely essential for success in this role
• Hands-on experience with clinical trial regulatory affairs in a CRO or pharmaceutical company (specifically regulatory work for clinical trials)
• Deep knowledge of regulatory submissions including local guidelines dossier requirements and global clinical trial application processes
• Advanced English proficiency
• Exceptional attention to detail paired with strong prioritization and organizational capabilities
• Excellent communication skills and the ability to influence at all organizational levels
• A collaborative mindset and team-oriented approach

Working at Novo Nordisk

For over 100 years weve been committed to defeating serious chronic diseases. Our work in clinical research is at the heart of this missioneach trial you help launch represents hope for patients living with diabetes obesity and other serious conditions. Youll be part of a global community that values precision quality and collaboration. Here your regulatory expertise matters your attention to detail makes a difference and your ability to navigate complexity helps bring innovative treatments to millions of patients worldwide. If youre ready to apply your skills in an environment where the work is challenging and the impact is real this is your opportunity.

Deadline

Apply before June 9th. Applications will be reviewed on an ongoing basis.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Were not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.