Clinical Country & Site Associate (Clinical Trial Manager) - Sponsor dedicated in Brazil, Indiana at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Country & Site Associate (Clinical Trial Manager) - Sponsor dedicated based in Brazil.

This is a field- and site-focused clinical operations role at the heart of global clinical research execution, supporting sponsor-dedicated studies across multiple therapeutic areas.
You will ensure that clinical trial sites operate in full compliance with regulatory standards, ICH-GCP guidelines, and study protocols while maintaining high-quality data integrity.
The role combines on-site and remote monitoring responsibilities, requiring strong attention to detail and a proactive, problem-solving mindset.
You will work closely with investigators, site staff, and cross-functional clinical teams to support study start-up, execution, and close-out activities.
This position plays a critical role in safeguarding patient safety, ensuring data accuracy, and driving study performance across assigned sites.
It offers exposure to complex, global clinical trials within a fast-paced, highly regulated environment where precision and communication are essential.

• Conduct site qualification, initiation, monitoring, and close-out visits (on-site and remote), ensuring compliance with study protocols, ICH-GCP, Good Pharmacoepidemiology Practices, and applicable regulatory requirements.
• Perform ongoing site management activities, including source document verification, case report form (CRF) review, query resolution, and tracking of site performance metrics.
• Ensure proper informed consent processes are followed and documented, while continuously assessing patient safety, protocol deviations, and pharmacovigilance-related issues.
• Review Investigator Site Files (ISF), reconcile with Trial Master File (TMF), and ensure documentation accuracy, completeness, and audit readiness.
• Support investigational product (IP) accountability, including storage, dispensing verification, reconciliation, and compliance with blinding and labeling requirements.
• Act as a primary liaison with site personnel, supporting communication, training compliance, recruitment strategies, and timely resolution of site-level issues.
• Prepare required study documentation, including trip reports, follow-up letters, and communication logs, while ensuring timely data entry into tracking systems.

• Bachelor’s degree in a life sciences, nursing, or related field, or equivalent combination of education and clinical research experience.
• Solid understanding of ICH-GCP guidelines, clinical trial regulations, and Good Clinical Practice standards in global research environments.
• Prior experience in clinical monitoring, site management, or clinical research operations (experience in sponsor- or CRO-led trials is highly desirable).
• Strong knowledge of clinical trial processes, including source data verification, EDC systems, and clinical documentation practices.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with investigators, site staff, and cross-functional teams.
• Strong organizational skills with the ability to manage multiple sites, prioritize tasks, and meet strict timelines in a regulated environment.
• Willingness to travel up to 75% and adapt to dynamic study needs and changing priorities.

• Opportunity to work on global clinical trials with high scientific and regulatory impact
• Exposure to sponsor-dedicated studies across leading therapeutic areas
• Flexible work arrangement with significant field-based and remote collaboration
• Strong focus on professional development, training, and career progression in clinical research
• Participation in high-impact studies contributing to patient access and healthcare innovation
• Collaborative, international work environment within a leading life sciences organization