Senior Study Start-Up Clinical Research Associate (SSU CRA)

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A; Santo Amaro; Presencial; BRL 150 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Annual bonus

Life insurance

Home office policy

Flexible working arrangements

Birthday day-off

Parental leave

Health insurance

Wellbeing plans

Resumo da oferta

Novartis is seeking a Senior Study Start-Up Clinical Research Associate (SSU CRA) based in São Paulo, Brazil. You will lead site readiness, regulatory submissions, and activation for trials across Brazil, building strong investigator and site partnerships in a collaborative, global environment.

You will ensure compliant, timely start-ups, maintain trial master files, and support cross-functional teams to accelerate site activation, while contributing to life-changing medicines for patients

Qualificações

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Minimum three years of clinical study start-up or relevant clinical research experience.
• Strong knowledge of clinical trial regulations, GCP/ICH, and regulatory requirements.

Responsabilidades

• Lead site selection activities and confirm site suitability for assigned clinical studies.
• Drive study start-up activities from site allocation through site activation and green light.
• Build strong relationships with investigators, research sites, and external partners.
• Prepare, collect, and maintain high-quality regulatory and site documentation.
• Support ethics committee and health authority submissions within agreed timelines.
• Ensure inspection-ready trial master file documentation and regulatory compliance.
• Partner with cross-functional teams to resolve issues and accelerate study start-up activities.

Conhecimentos

Site start-up

Regulatory knowledge

GCP/ICH

Stakeholder management

English proficiency

Portuguese proficiency

Formação académica

Bachelor’s degree in a scientific field

Ferramentas

CTMS (Veeva)

Descrição da oferta de emprego

Job Description Summary #LI-Hybrid Location: São Paulo, Brazil Relocation Support: This role is based in São Paulo, Brazil. Novartis is unable to offer relocation support: please only apply if accessible.

As a Senior Study Start-Up Clinical Research Associate (SSU CRA), you will play a critical role in bringing innovative medicines closer to patients by accelerating the successful start-up of clinical trials across Brazil. This is an opportunity to be at the forefront of clinical research, building trusted partnerships with investigators and study sites while ensuring studies are activated efficiently, compliantly, and on schedule. Working within a collaborative global environment, you will combine scientific expertise, strategic thinking, and relationship-building skills to overcome challenges, drive site readiness, and help deliver life-changing treatments to patients around the world.

Job Description Key Responsibilities

• Lead site selection activities and confirm site suitability for assigned clinical studies.
• Drive study start-up activities from site allocation through site activation and green light.
• Build strong relationships with investigators, research sites, and external partners.
• Prepare, collect, and maintain high-quality regulatory and site documentation.
• Support ethics committee and health authority submissions within agreed timelines.
• Ensure inspection-ready trial master file documentation and regulatory compliance.
• Partner with cross-functional teams to resolve issues and accelerate study start-up activities.

Essential Requirements

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Minimum three years of clinical study start-up or relevant clinical research experience.
• Strong knowledge of clinical trial regulations, Good Clinical Practice, and regulatory requirements.
• Experience managing study start-up activities, submissions, and site activation processes.
• Excellent relationship-building, negotiation, and stakeholder management skills.
• Fluent written and spoken English and local language proficiency as required.

Why Novartis

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive

• Competitive salary
• annual bonus
• life insurance
• home office policy (home office 2x a week)
• retirement and wellbeing plans
• flexible working arrangements
• birthday day-off
• parental leave
• subsidized dining facilities
• health insurance
• employee recognition platform
• Gympass
• employee resource groups
• virtual self-development tools

If you want to learn more about our benefits, you can access the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Careers: https://www.novartis.com/careers.

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.