Senior Site Navigator in Brazil, Indiana at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Site Navigator in Brazil.

This role is a key contributor within clinical operations, responsible for driving site start-up and activation activities across complex clinical studies. You will act as a regional or country-level expert, ensuring that investigative sites are properly engaged, prepared, and supported throughout the study initiation process. Operating with a high degree of autonomy, you will collaborate closely with internal study teams, regulatory stakeholders, and external partners to ensure timelines, quality, and compliance standards are consistently met. In addition to hands-on execution, you will serve as a mentor to junior professionals, helping strengthen team capability and operational excellence. This is a highly impactful position for someone who thrives in fast-paced, regulated environments and enjoys working at the intersection of strategy, execution, and stakeholder management.

In this role, you will lead end-to-end site start-up activities while ensuring compliance, quality, and timely delivery across assigned studies. You will act as a central point of contact for investigative sites and contribute directly to study success through coordination, negotiation, and oversight.

• Lead site start-up, feasibility assessments, pre-study visits, and activation activities across clinical studies.
• Serve as the primary liaison for investigative sites, ensuring clear communication and alignment on study requirements.
• Support regulatory and ethics submissions, including IRB/IEC documentation, renewals, and ongoing compliance.
• Manage contract and budget negotiations with sites to ensure timely execution and adherence to study scope.
• Collaborate with cross-functional teams (CRAs, study leads, vendors, and regulatory teams) to support study initiation and ongoing operations.
• Ensure Trial Master File (TMF) accuracy, inspection readiness, and system compliance.
• Identify, assess, and mitigate risks that may impact timelines, site performance, or regulatory compliance.
• Mentor and support junior Site Navigators, contributing to capability building within the team.

The ideal candidate brings strong clinical research experience, particularly in study start-up and regulatory processes, along with excellent communication and stakeholder management skills.

• University degree in Life Sciences or equivalent clinical research experience.
• 3+ years of experience in clinical research, study start-up, or regulatory operations.
• Strong knowledge of ICH-GCP guidelines, IRB/IEC processes, and clinical regulatory frameworks.
• Proven ability to manage multiple sites and complex study portfolios independently.
• Experience in contract and budget negotiation with clinical sites.
• Strong communication and interpersonal skills, with the ability to influence and collaborate across stakeholders.
• Leadership presence with mentoring capability for junior team members.
• Fluency in English and Portuguese (written and spoken).

• Fully remote or hybrid work flexibility depending on project needs.
• Opportunity to work on global clinical research programs with high impact.
• Exposure to complex, multinational study environments and leading pharmaceutical processes.
• Career development opportunities in clinical operations and leadership tracks.
• Collaborative, knowledge-sharing environment with mentoring responsibilities.
• Participation in meaningful work contributing to healthcare innovation and patient outcomes.