Analista De Pesquisa Clínica Sr (Pharma)

TL;DR

Analista De Pesquisa Clínica Sr (Pharma): Site management and monitoring of clinical trials to ensure patient safety and quality execution with an accent on GCP compliance and investigator site relationships. Focus on coordinating site initiation and close-out, resolving protocol issues, and ensuring rigorous data quality and regulatory adherence.

Location: Remote (Brazil), but requires significant travel (60-80%) to investigator sites

Company

A global pharmaceutical leader dedicated to discovering, developing, and delivering breakthrough therapies and vaccines.

What you will do

• Manage investigator sites from initiation through database lock, ensuring adherence to Study Monitoring Plans and GCP.
• Conduct onsite and remote monitoring activities to safeguard patient safety and data quality.
• Serve as the primary point of contact for assigned sites and facilitate communication between study teams and vendors.
• Identify and resolve site issues, developing corrective and preventative actions (CAPA).
• Monitor adverse events (AEs) and serious adverse events (SAEs) in collaboration with the Drug Safety Unit.
• Mentor and train junior Clinical Research Associates on site management processes.

Requirements

• Must be based in Brazil with a valid passport for potential international travel.
• Medical background or equivalent qualification.
• Minimum 3 years of experience in clinical research site monitoring (preferably 2 years in Oncology).
• Extensive knowledge of ICH/GCP, FDA, and local Brazilian regulations.
• Fluent English (C1) and Portuguese (C1) required.
• Ability to travel 60-80% of the time within the assigned area.

Nice to have

• Therapeutic experience in Vaccines, Internal Medicine, or Infectious Diseases.
• Experience with global clinical trials.

Culture & Benefits

• Opportunity to work with a global industry leader in pharmaceuticals.
• Remote work assignment for non-monitoring activities.
• Professional growth through mentoring and SME roles.
• Commitment to equal opportunity and diverse employment practices.