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

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.