Job Type: Contract

Job Category: IT

Job Description

Job Title: Veeva eTMF Consultant

Job Summary:

The Veeva eTMF Specialist is responsible for the setup, maintenance, and management of the Veeva Vault eTMF system, ensuring compliance with regulatory requirements and industry best practices. This role supports clinical trial teams by overseeing document management, user training, system configurations, and troubleshooting.

Key Responsibilities:

• Configure and maintain Veeva Vault eTMF, including user roles, permissions, and workflows.
• Ensure system compliance with regulatory standards (ICH-GCP, FDA, EMA, etc.).
• Monitor and maintain TMF completeness, accuracy, and audit readiness.
• Oversee the upload, classification, indexing, and version control of essential trial documents.
• Perform quality control (QC) reviews to ensure document accuracy and regulatory compliance.
• Work with study teams to ensure timely filing and completeness of TMF documentation.
• Provide training and user support for Veeva Vault eTMF.
• Develop and update SOPs, work instructions, and training materials.
• Act as the primary contact for troubleshooting and system-related inquiries.

Qualifications and Skills:

- Bachelor's degree in Life Sciences, Computer Science, or related field

- Minimum of 2 years of experience working with Veeva eTMF software

- Strong understanding of clinical trial documentation processes and regulations

- Excellent organizational and project management skills

- Ability to work independently and collaboratively with cross-functional teams

- Strong communication and interpersonal skills

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Required Skills