Roles & Responsibilities
• Manage electronic Trial Master File (eTMF) activities including Trial, Country, and Site artifacts in line with TMF processes
• Classify, review, and process documents through Smart Inbox and perform ARC reviews
• Conduct visual quality checks to ensure document clarity, readability, and completeness
• Perform Audit Ready Checks to maintain inspection-ready eTMF at all study stages
• Track, process, and maintain final essential documents across the clinical study lifecycle
• Ensure compliance with company SOPs, sponsor SOPs, GCP, ICH, and regulatory requirements
• Support QA and sponsor audits, identify issues, and implement corrective and preventive actions
• Collaborate with Business Process, Study, and cross-functional teams to meet project and client expectations
• Participate in internal and external study meetings as required
• Contribute to continuous improvement initiatives to enhance quality, productivity, and processes
Qualification
• Bachelor’s Degree in Life Sciences or Business
• Master’s Degree in Life Sciences or Business preferred
Experience
• 6-12 months of experience in a clinical research environment
• Equivalent clinical research experience may be considered
Skills
• Strong understanding of GCP, ICH guidelines, and regulatory documentation requirements
• Proficiency in Microsoft Office, web-based applications, and Adobe Acrobat
• Familiarity with clinical electronic systems is an advantage
• Excellent communication, interpersonal, and organizational skills
• High attention to detail and ability to manage multiple tasks
About the Company
Fortrea is a leading global Contract Research Organization dedicated to advancing clinical development through innovation, collaboration, and scientific excellence, helping transform lives by delivering high-quality clinical trials worldwide.
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