Clinical Trial Associate

Novartis; Schweiz; Hybrid; EUR 10.000 - 15.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Life insurance

Home office policy

Flexible working

Birthday day-off

Parental leave

Health insurance

Gympass

Self-development tools

Zusammenfassung

Novartis is seeking a Clinical Operations professional to support study start-up and deliver clinical trial activities across the full study lifecycle in Santo Amaro, Brazil. The role emphasizes regulatory submissions, TMF quality, and collaboration with investigators and vendors.

You will ensure compliance with GCP and Novartis standards while driving process improvements to enhance efficiency. A life sciences degree and English fluency are required; relocation support is not available.

Qualifikationen

• Bachelor’s degree or equivalent in life sciences.
• Experience supporting clinical trials in a regulated environment.
• Understanding of drug development and start-up processes.
• Knowledge of Good Clinical Practice and regulatory requirements.

Aufgaben

• 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.

Kenntnisse

Clinical trials experience

Regulatory knowledge

GCP knowledge

Project coordination

English fluency

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

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.

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. With our people, we 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 and virtual self-development tools.

Benefits Details

• 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