TMF Operations Specialist II - Precision & Compliance

Worldwide Clinical Trials; United States; Remote; USD 65,000 - 85,000; Full time

Job summary

Worldwide Clinical Trials in the United States is seeking a TMF Approver/QA Reviewer to ensure all Trial Master File documents meet regulatory requirements and company SOPs. You will process, review, and resolve TMF documents in electronic and hard copy formats, prepare quality control checklists, and participate in project team activities.

The role suits someone with up to 1–2 years TMF experience in CRO/Pharma, strong attention to detail, good written/verbal communication, and proficiency in

Qualifications

• Experience in managing TMF documents and data with attention to naming conventions.
• Ability to review and edit trial documents to meet SOPs and regulatory requirements.
• Strong written and verbal communication to clearly present information.

Responsibilities

• Fulfil TMF Approver and/or TMF QC Reviewer roles per SOPs.
• Process, review, and resolve rejected TMF documents for complex studies.
• Prepare periodic TMF Quality Control checklists for Project Team review.
• Perform periodic TMF Quality Control to ensure regulatory compliance and industry best practices.
• Work with electronic TMF systems to classify and process essential documents.

Skills

Data collection

Indexing

Editing

Written communication

Verbal communication

Interpersonal skills

Planning & organization

Word processing

Excel

eTMF systems

Clinical research knowledge

Education

University degree (Life Science desirable)

Tools

Microsoft Word

Microsoft Excel

Electronic TMF systems

Job description

Worldwide Clinical Trials in the United States is seeking a TMF Approver/QA Reviewer to ensure all Trial Master File documents meet regulatory requirements and company SOPs. You will process, review, and resolve TMF documents in electronic and hard copy formats, prepare quality control checklists, and participate in project team activities.

The role suits someone with up to 1–2 years TMF experience in CRO/Pharma, strong attention to detail, good written/verbal communication, and proficiency in