TMF Operations Specialist: Regulatory Compliance & Audits

Evolution Research Group; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

Evolution Research Group is seeking a TMF Specialist to manage site-level documentation within the electronic Trial Master File (eTMF). You will ensure timely filing, maintain audit readiness, and support study compliance across TMF tasks.

In this role, you will review documents, verify metadata and version control, and collaborate with Regulatory Operations and sponsors to resolve discrepancies, supporting audits and process improvements.

Qualifications

• Bachelor’s degree in biological sciences or related field.
• 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 the DIA TMF Reference Model is desirable.

Responsibilities

• Review, process, and approve TMF documents submitted to the eTMF, aligning with ISF and study filing requirements.
• Validate document quality by checking metadata accuracy, naming conventions, and version control prior to approval.
• Communicate with internal stakeholders to clarify document discrepancies and support timely resolution.
• File documents promptly to maintain a complete, inspection-ready TMF throughout the study lifecycle.
• Update and monitor the Expected Documents List (EDL) to reflect current document status per sponsor and regulatory standards.
• Use designated systems to manage document flow, track submissions, and flag potential quality issues.
• Provide operational support to Regulatory Specialists and Senior TMF Specialists across TMF tasks.
• Participate in TMF audit preparation activities and support audit response efforts.
• Contribute to TMF process improvements and assist with department initiatives for quality and compliance.
• Respond to document-related questions from internal teams and external partners; escalate complex issues as needed.
• Maintain familiarity with Lotus CRO/Sponsor SOPs, TMF best practices, and applicable regulatory guidelines.
• Assist with document intake and categorization from sites and vendors; ensure timely routing.
• Monitor TMF completeness reports and elevate gaps or delays to senior staff.

Skills

Regulatory knowledge

GCP/ICH knowledge

Documentation management

Attention to detail

Communication skills

Microsoft Office

Time management

Multi-tasking

Education

Bachelor's degree in biological sciences

1 year clinical research/regulatory ops experience

Tools

Veeva Vault

eTMF platforms

Job description

Evolution Research Group is seeking a TMF Specialist to manage site-level documentation within the electronic Trial Master File (eTMF). You will ensure timely filing, maintain audit readiness, and support study compliance across TMF tasks.

In this role, you will review documents, verify metadata and version control, and collaborate with Regulatory Operations and sponsors to resolve discrepancies, supporting audits and process improvements.