Essential Document Pack Reviewer – Clinical Trials – FSP

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🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $93k - $125k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔍🏥 Medical Reviewer

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Independently review country-level essential documents for completeness, accuracy, quality, and compliance with the applicable Essential Document Compliance checklist • Independently review site-level essential documents required for clinical trial site activation • Confirm required essential regulatory documentation meets study, sponsor, SOP, and regulatory requirements • Identify documentation deficiencies, inconsistencies, missing information, and quality concerns • Communicate review outcomes and required corrections to submitters and study team members • Review revised document packages to confirm deficiencies are resolved • Communicate final review outcomes to Study Start-Up Specialists and stakeholders • Track EDP review activities and outcomes in systems and databases • Maintain knowledge of SOPs, study requirements, and regulatory guidelines • Apply independent judgment to assess clinical trial documentation • Partner with study teams to support timely and compliant site activation

🎯 Requirements

• Bachelor's degree or equivalent combination of education and relevant experience • 2+ years of relevant clinical research experience, including hands-on clinical trial regulatory or essential documentation experience • Experience reviewing clinical trial documentation for completeness, accuracy, quality, and/or regulatory compliance • Experience in clinical trial essential document review, study or site start-up, clinical regulatory documentation, site activation, regulatory start-up, or TMF/eTMF documentation • Working knowledge of SOPs, clinical trial documentation requirements, and applicable regulatory guidelines • Ability to identify documentation deficiencies and communicate required corrections independently • Strong attention to detail, quality, and document accuracy • Strong written and verbal English communication skills; local language proficiency where applicable • Ability to work independently, exercise sound judgment, and manage multiple priorities and timelines • Strong analytical, investigative, and problem-solving skills • Proficiency with Microsoft Word, Excel, and PowerPoint • Preferred: experience in a CRO, pharmaceutical, biotechnology, or clinical research environment • Preferred: multinational or country-level clinical trial start-up experience • Preferred: familiarity with ICH-GCP and global, regional, and country-specific regulatory requirements

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities • Equal Opportunity Employer