Senior Site Navigator

Reposted 5 Hours Ago
Be an Early Applicant
Hiring Remotely in São Paulo, BRA
In-Office or Remote
Senior level
Biotech
The Role
The Senior Site Navigator leads study start-up activities, manages site interactions, mentors colleagues, handles contract negotiations, and ensures regulatory compliance.
Summary Generated by Built In

Senior Site Navigator
Job Code: 700344 Job Level: P2 | Individual Contributor Function: Clinical Operations Work Model: Remote / Office-based with travel as needed
About the Role
As a Senior Site Navigator, you’ll act as a local country or regional expert in study start-up, leading site-level activities with minimal oversight. You’ll be a trusted partner to sites and internal teams, proactively identifying risks, mentoring junior colleagues, and ensuring studies move forward efficiently and compliantly. [700344 - S...Navigator | PDF]
What You’ll Be Doing

Lead and oversee site start-up and activation activities across assigned studies

Act as a knowledge resource and mentor for junior Site Navigators

Manage site outreach, feasibility, pre-study visits, and regulatory documentation

Serve as the primary site contact, ensuring high-quality delivery aligned with study scope and budgets

Support IRB/IEC and regulatory authority submissions, renewals, and compliance activities

Lead contract and budget negotiations with investigative sites

Ensure TMF accuracy, inspection readiness, and system compliance

Collaborate with CRAs, study leads, vendors, and regulatory teams to support SIVs and ongoing study needs

Anticipate and mitigate risks that may impact timelines or site performance

Participate in remote and on-site activities as required to support study success [700344 - S...Navigator | PDF]
What We’re Looking For
Education & Experience

University/College degree (life sciences preferred) or equivalent clinical research experience

3+ years of experience in clinical research, start-up, or regulatory processes

Strong hands-on knowledge of ICH/GCP, IRB/IEC, and regulatory frameworks
Skills & Competencies

Proven ability to manage complex site portfolios independently

Strong negotiation skills (contracts and budgets)

Excellent stakeholder communication and leadership presence

Ability to mentor, guide, and influence others

Fluency in English and the local official language (written and spoken) [700344 - S...Navigator | PDF]
Why This Role?
This role is ideal for experienced professionals ready to lead, mentor, and shape site start-up strategy, while continuing to grow within a high-impact clinical operations environment.

Learn more about our EEO & Accommodations request here.

Skills Required

  • University/College degree or equivalent clinical research experience
  • 3+ years of experience in clinical research, start-up, or regulatory processes
  • Strong hands-on knowledge of ICH/GCP, IRB/IEC, and regulatory frameworks
  • Strong negotiation skills (contracts and budgets)
  • Fluency in English and the local official language (written and spoken)
Am I A Good Fit?
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The Company
HQ: Research Triangle Park, NC
10,811 Employees

What We Do

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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