Local Clinical Study Associate - Study Operations (Vaga também afirmativa PCD)

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.
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.

 

Job Description

Key Responsibilities

• Coordinate local study execution across regulatory, legal, quality, research sites, and contract research organizations.
• Support study start‑up activities, including confidentiality agreements, study registration, and required site documentation.
• Collaborate with project teams to track milestones, manage issues, and support recruitment and data quality activities.
• Ensure research sites are prepared for study initiation and maintain documentation throughout the study lifecycle.
• Maintain country and site Trial Master Files to ensure accuracy, completeness, and inspection readiness.
• Monitor clinical data collection and reporting to support quality, compliance, and timely study delivery.
• Contribute to audit and inspection readiness and support clinical study report and publication activities.

Essential Requirements

• Solid understanding of clinical research principles and real‑world evidence methodology.
• Strong knowledge of International Council for Harmonisation Good Clinical Practice guidelines and local regulatory requirements.
• Experience supporting clinical study start‑up, maintenance, and close‑out activities.
• Familiarity with Trial Master File management, clinical trial management systems, and regulatory documentation.
• Strong organizational and planning skills, with high attention to detail and compliance.
• Ability to collaborate effectively with research sites and cross‑functional teams in a structured environment.

Desirable Requirements

• Experience supporting audit and inspection activities, including preparation of study documentation and evidence.
• Experience supporting clinical study report development and publication readiness processes.

 

Skills Desired

Clinical Trials, Conflict Management, Contract Management, Effective Communication, Financial Analysis, Negotiation Skills