Clinical Trial Associate

Novartis; Santo Amaro; Presencial; BRL 60 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Health insurance

Home office policy

Retirement plan

Resumo da oferta

Novartis in Santo Amaro, Brazil, invites applications for a Clinical Trial Associate to support study start-up and delivery across the full lifecycle. You will coordinate regulatory submissions, maintain trial master files, and ensure readiness for inspections, collaborating with cross-functional teams and external partners.

The role requires life sciences education, experience in regulated clinical operations, and excellence in English communication, with a hybrid work environment and access to

Qualificações

• Bachelor’s degree or equivalent in life sciences or related field.
• Experience supporting clinical trials or clinical operations in a regulated environment.
• Understanding of clinical drug development and study start-up processes.
• Knowledge of Good Clinical Practice and regulatory requirements guiding clinical research.
• Strong organisational skills with the ability to manage multiple priorities.
• Excellent written and spoken English.

Responsabilidades

• Support study start-up activities and clinical trial delivery across the full study lifecycle.
• Prepare, collect, and manage essential documentation for regulatory and ethics submissions.
• Maintain trial master files and ensure document quality and inspection readiness.
• Coordinate site activation activities and verify requirements for study drug release.
• Collaborate with vendors, investigators, and cross-functional teams to meet milestones.
• Ensure compliance with regulatory requirements, GCP, and Novartis standards.
• Drive process improvements to enhance efficiency and study execution.

Conhecimentos

Regulatory knowledge

Project coordination

Communication

Formação académica

Life sciences degree

Descrição da oferta de emprego

Job Description Summary

#LI-Hybrid

Location: Santo Amaro, Brazil

Relocation Support: This role is based in Santo Amaro, Brazil. Novartis is unable to offer relocation support: please only apply if accessible.

Are you passionate about bringing innovative medicines to patients faster? As a Clinical Trial Associate, you will play a vital role in the successful start-up and delivery of global clinical studies, helping ensure sites are ready, compliant, and equipped to advance groundbreaking research. Working closely with cross-functional teams, investigators, and external partners, you will support critical study activities throughout the clinical trial lifecycle, making a direct impact on the quality, efficiency, and success of clinical development at Novartis.

Job Description

Key Responsibilities

• Support study start-up activities and clinical trial delivery throughout the full study lifecycle.
• Prepare, collect, and manage essential documentation for regulatory and ethics submissions.
• Maintain trial master files and ensure document quality, completeness, and inspection readiness.
• Coordinate site activation activities and verify requirements for study drug release.
• Collaborate with vendors, investigators, and cross-functional teams to achieve study milestones.
• Ensure compliance with regulatory requirements, Good Clinical Practice, and Novartis standards.
• Drive process improvements that enhance operational efficiency and study execution.

Essential Requirements

• Bachelor’s degree, vocational qualification, or equivalent education in a life sciences or related field.
• Experience supporting clinical trials or clinical operations within a regulated environment.
• Understanding of clinical drug development and study start-up processes.
• Knowledge of Good Clinical Practice and regulatory requirements governing clinical research.
• Strong organisational skills with the ability to manage multiple priorities effectively.
• Excellent communication and collaboration skills with fluency in written and spoken English.

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! 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