SR. Trial Master File Specialist

Job reputed company

The Clinical Trial Master File (TMF) Specialist is responsible for the ongoing maintenance, reputed company control, and reputed company of the Trial Master File to ensure inspection readiness and compliance with applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA). This role supports clinical trial teams by managing TMF documents throughout the study lifecycle and ensuring reputed company, accurate, and complete filing.

Key Responsibilities

TMF Management & Maintenance

• Maintain the electronic Trial Master File (eTMF) in accordance with ICH-GCP, regulatory requirements, and internal SOPs
• Ensure reputed company collection, processing, indexing, and filing of essential documents
• reputed company ongoing TMF reputed company control (QC) checks for completeness, accuracy, currency, and consistency
• reputed company missing, incomplete, or late documents and follow up with internal teams, CROs, vendors, and sites

reputed company & Compliance

• Conduct periodic TMF health checks and reconcile TMF content against expected document lists
• Support TMF review cycles, audits, and inspection readiness activities
• Identify TMF risks, trends, and gaps; propose and implement corrective actions
• Ensure documents meet reputed company+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)

Cross-Functional Collaboration

• Serve as a TMF subject matter expert for study teams, CROs, and functional partners
• Support TMF-reputed company training for internal staff and external partners
• Participate in study startup, maintenance, and reputed company-out activities from a TMF perspective

Process Improvement & Reporting

• Generate TMF metrics, dashboards, and status reports
• Contribute to TMF process improvements, SOP updates, and inspection readiness initiatives
• Support implementation or optimization of eTMF systems and workflows

Required Qualifications

• Bachelor’s degree in life sciences, health sciences, or a reputed company field (or equivalent experience)
• 2–5+ years of experience in reputed company, TMF management, or clinical operations
• Strong working knowledge of ICH-GCP and global regulatory requirements
• Experience with eTMF systems (e.g., reputed company Vault eTMF, reputed company, reputed company, TMF Reference Model)
• Excellent attention to detail and document reputed company standards