Remote TMF Operations Associate II — Quality & Docs

Worldwide Clinical Trials; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure TMF documents are accurate, complete, and audit-ready across complex studies. You will process, review, and manage documents in electronic and hard-copy formats while collaborating with global teams in a remote capacity.

The role emphasizes TMF quality control, document indexing, and adherence to ICH GCP and regulatory standards, with opportunities to contribute to process improvements within a fast-paced CRO

Qualifications

• University degree preferred; life science discipline ideal.
• Up to 2 years TMF experience in CRO/pharma environment.
• Proficiency in English (written and verbal).
• Experience with data collection, document indexing, editing, and standardized naming.
• Strong attention to detail with ability to manage multiple tasks and meet deadlines.
• Effective planning, organizational and interpersonal skills in a fast-paced environment.
• Proficiency with Word and Excel; familiarity with electronic document repositories or eTMF systems.

Responsibilities

• Perform TMF Approver and TMF Quality Control Reviewer activities per procedures.
• Process, review, and resolve rejected TMF documents for complex studies.
• Manage essential documents in electronic and hard-copy formats.
• Prepare periodic TMF Quality Control checklists for project team review.
• Conduct regular quality checks to ensure regulatory compliance and industry standards.
• Review, classify, index, and process essential documents in TMF systems.
• Apply consistent document naming and filing standards for accuracy.
• Collaborate with global teams to address documentation issues and support TMF quality.

Skills

Attention to detail

Multi-tasking

Communication skills

Planning & organization

English proficiency

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

Microsoft Excel

eTMF systems

Document management systems

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure TMF documents are accurate, complete, and audit-ready across complex studies. You will process, review, and manage documents in electronic and hard-copy formats while collaborating with global teams in a remote capacity.

The role emphasizes TMF quality control, document indexing, and adherence to ICH GCP and regulatory standards, with opportunities to contribute to process improvements within a fast-paced CRO