TMF Specialist (All

Key Responsibilities

• Document Processing:
• Process study documents in line with client-specific and study-specific requirements, following ICON SOPs/WPs and applicable regulatory guidelines.
• Collaboration:
• Liaise with study teams and TMF staff to ensure accurate and timely document handling and task completion.
• Project Execution:
• Complete departmental projects within established timelines, maintaining compliance with all relevant regulations.
• File Maintenance:
• Maintain study files in accordance with study/client specifications, ensuring consistency and accuracy.
• Document Management:
• Handle document receipt and processing, including:
• Scanning
• Indexing
• Quality control
• Copying
• Filing
• Archiving
• Reporting:
• Provide status updates and necessary information for client and departmental reports upon request.
• Issue Escalation:
• Notify the Manager regarding:
• Training needs
• Project activities
• Quality concerns
• Timeline risks
• Document Requests:
• Supply copies of study documents to ICON or client personnel as required.
• Audit Support:
• Participate in client and ICON audits and assist with document archiving activities as needed.
• Training:
• Engage in ICON/client-mandated training relevant to your role and responsibilities.
• Other Duties:
• Perform special projects or additional tasks assigned by the Manager.

Requirements

Experience

• 115 years of experience working with TMF (Trial Master File)
• Strong understanding of clinical study documentation and GCP compliance

Skills

• Excellent oral and written communication skills
• Proven ability to collaborate effectively with cross-functional teams, clients, and leadership
• Detail-oriented with a focus on accuracy and regulatory compliance

Education

• Bachelor's degree in Life Sciences (preferred)
• Equivalent experience in clinical documentation may be considered