Senior TMF Operations Specialist

Worldwide Clinical Trials; Georgia; On-site; USD 85,000 - 120,000; Full time

Job summary

Worldwide Clinical Trials is seeking a TMF Operations professional to manage and oversee documentation, quality control, and regulatory compliance across multiple studies in a fast-paced, highly regulated environment.

You will work with Project Teams and Sponsors to ensure TMF integrity, prepare KPI reports, and support audits. The role requires a strong foundation in clinical research principles and the ability to deliver compliant solutions under pressure.

Qualifications

• Understand TMF management within regulated environments.
• Strong planning and organizational abilities.
• Excellent written and verbal communication.
• Ability to propose regulatory compliant solutions.

Responsibilities

• Perform TMF lead activities for multiple studies.
• Coordinate with Project Team and Sponsors to assess needs.
• Oversee TMF quality control processes and documentation.
• Develop TMF quality management documents.
• Prepare TMF KPIs and data analysis trends.
• Support regulatory and sponsor audits and findings resolution.

Skills

Planning skills

Organizational skills

Interpersonal skills

Written and verbal communication

Regulatory compliance

Education

University degree (Life Science) preferred

Job description

Worldwide Clinical Trials is seeking a TMF Operations professional to manage and oversee documentation, quality control, and regulatory compliance across multiple studies in a fast-paced, highly regulated environment.

You will work with Project Teams and Sponsors to ensure TMF integrity, prepare KPI reports, and support audits. The role requires a strong foundation in clinical research principles and the ability to deliver compliant solutions under pressure.