TMF Operations & QC Associate II

Worldwide Clinical Trials; United States; Remote; USD 45,000 - 65,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Records Management professional to join the TMF Operations team in the US. The role focuses on processing, reviewing and archiving Trial Master File documents in compliance with SOPs and regulatory standards.

Ideal candidates have 1–2 years of TMF experience in CRO/Pharma and a life sciences background, with strong data handling, communication and organizational skills. Equal opportunity employer committed to diversity.

Qualifications

• University degree preferred (Life Science desirable).
• 1–2 years TMF experience within CRO/Pharma preferred.

Responsibilities

• Fulfil TMF Approver and/or TMF QC Reviewer roles as 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.
• Work with Electronic Document Management and TMF systems to review and process documents.

Skills

Data collection

Editing

Communication

Interpersonal skills

Organizational skills

Word & Excel

eTMF

Clinical research

Education

Bachelor’s degree in Life Sciences

Tools

eTMF systems

Document management software

Job description

Worldwide Clinical Trials is seeking a Records Management professional to join the TMF Operations team in the US. The role focuses on processing, reviewing and archiving Trial Master File documents in compliance with SOPs and regulatory standards.

Ideal candidates have 1–2 years of TMF experience in CRO/Pharma and a life sciences background, with strong data handling, communication and organizational skills. Equal opportunity employer committed to diversity.