Postúlate en Kit Empleo: kitempleo.com.ar/empleo/okram

By continuing to use and navigate this website, you are agreeing to the use of cookies.
Accept Close

Search by Keyword

Search by Location

Loading...

Category

Select how often (in days) to receive an alert:

×

Select how often (in days) to receive an alert:

Study Start-Up Analyst

Category: Clinical Development

Location:

Vicente Lopez, Buenos Aires, AR

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, you'll own the end-to-end execution of study start-up and submission activities for assigned clinical trials. You'll 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 studies-navigating 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, you'll 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

We're looking for a clinical regulatory professional who combines technical expertise with strong stakeholder management and a solutions-oriented mindset. You'll need:

- A university degree in Life Sciences, Pharmacy, or a related field (required); an advanced degree is preferred
- Demonstrated experience in clinical research-this 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 general 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, we've been committed to defeating serious chronic diseases. Our work in clinical research is at the heart of this mission-each trial you help launch represents hope for patients living with diabetes, obesity, and other serious conditions. You'll 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 you're 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 May 8th. Applications will be reviewed on an ongoing basis.

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

We're not your typical healthcare company. In 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.

Postúlate en Kit Empleo: kitempleo.com.ar/empleo/okram

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