💼 About This Role

You'll lead end-to-end site start-up activities for complex clinical studies, ensuring compliance and timely delivery. Acting as a primary liaison for investigative sites, you'll drive regulatory submissions and contract negotiations. This role offers high autonomy and mentoring responsibilities in a fast-paced regulated environment.

🎯 What You'll Do

• Lead site start-up, feasibility assessments, and activation activities.
• Serve as primary liaison for investigative sites on study requirements.
• Support regulatory and ethics submissions including IRB/IEC documentation.
• Manage contract and budget negotiations with clinical sites.
• Ensure Trial Master File accuracy and inspection readiness.

📋 Requirements

• 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 regulatory frameworks.
• Fluency in English and Portuguese (written and spoken).

✨ Nice to Have

• Experience in contract and budget negotiation with clinical sites.
• Mentoring capability for junior team members.
• Leadership presence with cross-functional collaboration skills.

🎁 Benefits & Perks

• 🏢 Remote or hybrid work flexibility depending on project needs.
• 🌍 Global clinical research programs with high impact.
• 📈 Career development opportunities in clinical operations and leadership.
• 🤝 Collaborative, knowledge-sharing environment with mentoring responsibilities.
• 💡 Participation in meaningful work contributing to healthcare innovation.

📨 Hiring Process

Estimated timeline: 2-3 weeks · AI estimate

1. 1Recruiter call· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical/behavioral interview· 60 min