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

Novartis Brasil; São Paulo; Presencial; BRL 120 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Annual bonus

Life insurance

Home office policy (home office 2x a-?

retirement and wellbeing plans

Flexible working arrangements

Birthday day-off

Parental leave

Subsidized dining facilities

Health insurance

Employee recognition platform

Gympass

Employee resource groups and virtual \

Resumo da oferta

Novartis Brasil in São Paulo, Brazil, seeks a Senior Study Start-Up Clinical Research Associate (SSU CRA) to accelerate trial start-up and ensure regulatory compliance. You will build partnerships with investigators and sites, manage submissions, and drive activation in a fast-paced global environment.

Ideal candidates have a scientific/healthcare degree, 3+ years in start-up or CRO-like roles, and strong GCP knowledge with English and local language fluency.

Qualificações

• Bachelor’s degree in science, healthcare, or related field.
• Minimum three years of clinical start-up or related clinical research experience.
• Knowledge of GCP and regulatory requirements; good documentation practices.
• Experience with site start-up, submissions, and activation processes.

Responsabilidades

• Lead site selection and assess suitability for trials.
• Drive start-up activities from allocation to site activation and green light.
• Build relationships with investigators, sites, and external partners.
• Prepare and maintain regulatory and site documentation.
• Support ethics committee and health authority submissions on time.
• Ensure inspection-ready master file and regulatory compliance.
• Collaborate with cross-functional teams to resolve start-up issues.

Conhecimentos

Bachelor’s degree

Clinical research experience

Regulatory knowledge

Site activation

Stakeholder management

English & local language proficiency

Formação académica

Bachelor's degree in science/healthcare/related

Descrição da oferta de emprego

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.

About The Role

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. How can we achieve this? 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!

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 and virtual self-development tools.

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.

Benefits and Rewards

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)