Study Start-Up Analyst

Novo Nordisk A/S; Buenos Aires; Híbrido; ARS 1.339.000 - 2.009.000; Jornada completa

Descripción de la vacante

Novo Nordisk is seeking a Study Start Up Analyst in Argentina to lead start-up and submission activities for assigned trials, from planning to green light. You will coordinate dossier preparation for Health Authorities and Ethics Committees, ensuring compliance with ICH GCP and local regulations and aligning with Novo Nordisk processes.

You will translate and validate key documents, manage milestones with Trial Managers, and proactively identify risks while supporting inspections and regulatory

Formación

• University degree in Life Sciences, Pharmacy or a related field.
• Experience in regulatory work for clinical trials at a CRO or pharmaceutical company, with hands-on ICH GCP experience.
• 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 work.
• A team player mindset.

Responsabilidades

• Lead and coordinate the preparation, review and submission of Health Authority and Ethics Committee dossiers for 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 support inspection readiness, audits and inspections.
• Share local regulatory insights with trial teams and regional and global colleagues, and contribute to improving how start-up and submissions work.

Conocimientos

Regulatory experience

ICH GCP knowledge

English proficiency

Attention to detail

Team player

Educación

Bachelors in Life Sciences, Pharmacy or related

Herramientas

CTMS

eTMF

Descripción del empleo

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Department: Clinical Trial Operations, International Operations

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.
• 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 support inspection readiness, audits and inspections
• Share local regulatory insights with trial teams and regional and global colleagues, and contribute to improving how start-up and submissions work

Who you’ll work with

You will join Clinical Trial Operations team and report to Adriana Demes, Trial Start-Up Manager. Every day, you will work with Trial Managers and local trial teams.

You will also build strong relationships with trial sites, Ethics Committees, Health Authorities and vendors. Good teamwork here keeps trials on track.

What you can expect here

You will own important work from the start, and your ideas will be heard. You will learn from experts in clinical, regulatory and quality, and build skills that help you grow. We move fast, support each other and never compromise on patient safety or quality.

Novo Nordisk is an equal opportunity employer. We welcome applications from all qualified candidates. Every application is considered without regard to gender, gender identity, sexual orientation, age, ethnicity, nationality, religion, disability, marital status or any other characteristic protected by law. If you need adjustments during the recruitment process, let us know.