Local Clinical Study Associate - Study Operations (vaga Também Afirmativa Pcd)

Stellen Nordrhein Westfalen

São Paulo, Brazil
Hybrid
Clinical study start-up coordination
Trial master file management
Good clinical practice compliance
In this role, you will support the execution of local clinical studies, working closely with research sites, contract research organizations, and internal teams across regulatory, legal, and quality

Job Summary

  • In this role, you will support the execution of local clinical studies, working closely with research sites, contract research organizations, and internal teams across regulatory, legal, and quality.
  • You will help coordinate study start up activities, track milestones, and ensure study documentation is accurate, complete, and inspection ready throughout the study lifecycle.
  • The position requires strong organization, attention to detail, and consistent collaboration to ensure studies are conducted in line with regulatory requirements, Good Clinical Practice standards, and Novartis processes.

Matching Summary

In this role, you will support the execution of local clinical studies, working closely with research sites, contract research organizations, and internal teams across regulatory, legal, and quality.

Skills & Requirements

Must-have

  • Clinical study start-up coordination
  • Trial Master File management
  • Good Clinical Practice compliance
  • Regulatory documentation management
  • Collaboration with research sites and CROs

Nice-to-have

  • Audit and inspection support
  • Clinical study report development
  • Effective communication
  • Conflict management
  • Negotiation skills

Key Requirements

  • Understanding of clinical research principles
  • Knowledge of ICH Good Clinical Practice guidelines
  • Experience in clinical study start-up and close-out
  • Familiarity with clinical trial management systems
  • Experience supporting audit and inspection activities

Work Rights

Must be accessible to work in São Paulo, Brazil; no relocation support

Tailored Resume

Cover Letter