Clinical Trial Start-Up Specialist

Novo Nordisk; La Lucila del Mar; Híbrido; ARS 1.200.000 - 1.600.000; Jornada completa

Descripción de la vacante

Novo Nordisk is seeking a Study Start Up Analyst for Vicente López, Buenos Aires, with hybrid working. You will own start-up and submission activities for assigned trials, ensuring timely and compliant Health Authority and Ethics Committee dossiers in line with ICH GCP.

You will collaborate with Trial Managers and local teams, translate key documents, manage regulatory milestones, and support inspection readiness to ensure high-quality clinical trials with patient safety at the forefront.

Formación

• University degree in Life Sciences, Pharmacy or related field.
• Experience in regulatory work for clinical trials at a CRO or pharmaceutical company.
• Hands-on experience with ICH GCP.
• Experience with trial systems CTMS and eTMF.
• Knowledge of regulatory submissions and local rules.
• Advanced English.

Responsabilidades

• Own start-up and submission activities for assigned trials.
• Lead preparation, review and submission of Health Authority and Ethics Committee dossiers.
• Co-develop the start-up plan and track milestones at country/site level.
• Adapt, translate and validate key documents including informed consent forms.
• Drive green light activities and keep trial registries and safety submissions up to date.
• Identify site-level risks and support inspections and audits.

Conocimientos

Regulatory submissions

ICH GCP

English proficiency

Documentation & detail orientation

Strong communication skills

Team player

CTMS/eTMF experience

Educación

Bachelor's degree in Life Sciences or Pharmacy

Herramientas

CTMS

eTMF

Descripción del empleo

Novo Nordisk is seeking a Study Start Up Analyst for Vicente López, Buenos Aires, with hybrid working. You will own start-up and submission activities for assigned trials, ensuring timely and compliant Health Authority and Ethics Committee dossiers in line with ICH GCP.

You will collaborate with Trial Managers and local teams, translate key documents, manage regulatory milestones, and support inspection readiness to ensure high-quality clinical trials with patient safety at the forefront.