eTMF & TMF Operations Specialist

Evolution Research Group; United States; Remote; USD 60,000 - 85,000; Full time

Job summary

Evolution Research Group seeks a TMF Specialist to manage site-level documentation in the electronic Trial Master File (eTMF). The role ensures timely filing, audit readiness, and adherence to regulatory standards.

Collaboration with internal teams and support across TMF tasks are essential to maintain documentation quality. Qualifications include a Bachelor’s in a biological field and 1+ year in clinical research or regulatory operations, with strong experience in eTMF systems and Veeva Vault

Qualifications

• Bachelor’s degree in biological sciences or related field preferred.
• At least 1 year of experience in clinical research, document management, or regulatory operations.
• Experience with electronic document management systems and eTMF platforms (e.g., Veeva Vault) strongly preferred.
• Familiarity with GCP, ICH guidelines, and DIA TMF Reference Model desirable.

Responsibilities

• Review, process, and approve TMF documents submitted to the electronic TMF (eTMF).
• Validate document quality by checking metadata accuracy and version control.
• Communicate with internal stakeholders to resolve discrepancies.
• File documents to maintain inspection-ready TMF throughout the study lifecycle.
• Update and monitor the Expected Documents List (EDL) to reflect current status.
• Use systems and tools to manage document flow, track submissions, and flag quality issues.
• Provide operational support to Regulatory Specialists and Senior TMF Specialists.
• Assist in TMF audit preparation and audit responses.
• Contribute to TMF process improvements and department initiatives.
• Respond to document-related questions and escalate complex issues.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Microsoft Office

Time management

Organizational skills

Multitasking

eTMF experience

Veeva Vault familiarity

Education

Bachelor’s degree in biological sciences or related field

1 year of clinical research/document management/regulatory operations

Tools

Veeva Vault

eTMF systems

Job description

Evolution Research Group seeks a TMF Specialist to manage site-level documentation in the electronic Trial Master File (eTMF). The role ensures timely filing, audit readiness, and adherence to regulatory standards.

Collaboration with internal teams and support across TMF tasks are essential to maintain documentation quality. Qualifications include a Bachelor’s in a biological field and 1+ year in clinical research or regulatory operations, with strong experience in eTMF systems and Veeva Vault