TMF Specialist: Regulatory Operations & Audit-Ready Docs

Lotus Clinical Research, LLC; Northern (KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Lotus Clinical Research, LLC is seeking a TMF Specialist to manage and review site-level documentation within the electronic Trial Master File (eTMF). The role supports regulatory operations, maintains audit readiness, and collaborates with cross-functional teams to ensure regulatory compliance and document quality throughout the study lifecycle.

The position requires a bachelor’s degree in biological sciences (preferred) and 1+ year of clinical research or regulatory operations experience, with

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.

Responsibilities

• Review, process, and approve TMF documents submitted to the eTMF.
• Validate document quality by checking metadata accuracy and version control.
• Communicate with internal stakeholders to resolve discrepancies.
• File documents promptly to maintain an inspection-ready TMF.
• Update the Expected Documents List (EDL) to reflect current status.
• Manage document flow and track submissions using designated systems.
• Provide operational support to Regulatory Specialists and Senior TMF Specialists.
• Assist in TMF audit preparation and audit response efforts.
• Contribute to TMF process improvements and document quality initiatives.
• Respond to document-related questions from internal teams and partners.

Skills

Regulatory knowledge

GCP/ICH familiarity

Document management

Communication skills

Time management

Organizational skills

Multitasking

Education

Bachelor’s degree in biological sciences or related field

Tools

Veeva Vault

eTMF systems

Microsoft Office

Job description

Lotus Clinical Research, LLC is seeking a TMF Specialist to manage and review site-level documentation within the electronic Trial Master File (eTMF). The role supports regulatory operations, maintains audit readiness, and collaborates with cross-functional teams to ensure regulatory compliance and document quality throughout the study lifecycle.

The position requires a bachelor’s degree in biological sciences (preferred) and 1+ year of clinical research or regulatory operations experience, with