Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

IEC 61508 Standard Contract Management Regulatory Compliance Application Portfolio Management Regulatory Compliance Risk Mitigation Vendor Management Feasibility Studies DOT (Department Of Transportation) Inspections Compliance Management +4 more

Other Skills

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Teamwork
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Mentorship
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Executive Presence

Roles & Responsibilities

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
Fluency in English and the local official language (written and spoken)

Requirements:

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

Job description

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
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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
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Support IRB/IEC and regulatory authority submissions, renewals, and compliance activities
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Lead contract and budget negotiations with investigative sites
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Ensure TMF accuracy, inspection readiness, and system compliance
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Collaborate with CRAs, study leads, vendors, and regulatory teams to support SIVs and ongoing study needs
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Anticipate and mitigate risks that may impact timelines or site performance
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Participate in remote and on-site activities as required to support study success [700344 - S...Navigator | PDF]
What We’re Looking For
Education & Experience
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University/College degree (life sciences preferred) or equivalent clinical research experience
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3+ years of experience in clinical research, start-up, or regulatory processes
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Strong hands-on knowledge of ICH/GCP, IRB/IEC, and regulatory frameworks
Skills & Competencies
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Proven ability to manage complex site portfolios independently
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Strong negotiation skills (contracts and budgets)
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Excellent stakeholder communication and leadership presence
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Ability to mentor, guide, and influence others
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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.