TMF Records Specialist - Quality & Compliance

Worldwide Clinical Trials; EUA; Teletrabalho; USD 60 000 - 85 000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials in the United States is seeking a TMF Records Management Compliance professional to support Trial Master File processes, quality control, and regulatory compliance across studies. You will help ensure TMF integrity, and oversee document handling in electronic and paper formats.

The role emphasizes TMF approval and QC review, resolving document issues, and maintaining robust document management practices using eTMF systems.

Qualificações

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

Responsabilidades

• Fulfil the “TMF Approver” and/or “TMF QC Reviewer” roles as defined by SOPs and practices.
• Process, review, and resolve rejected TMF documents for complex studies or Sponsor portfolio, in electronic and hard copy formats.
• Prepare periodic TMF Quality Control checklists for review by Project Team.
• Perform periodic TMF Quality Control to ensure regulatory, ICH GCP, Sponsor, and industry best practices.
• Work with Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.

Conhecimentos

Data collection

Indexing

Editing skills

Written comms

Interpersonal skills

Attention to detail

MS Word

MS Excel

eTMF systems

Document management

Formação académica

University degree preferred

Life science background desirable

TMF experience in CRO/Pharma (1–2 years)

Ferramentas

Electronic document management systems

eTMF experience

Descrição da oferta de emprego

Worldwide Clinical Trials in the United States is seeking a TMF Records Management Compliance professional to support Trial Master File processes, quality control, and regulatory compliance across studies. You will help ensure TMF integrity, and oversee document handling in electronic and paper formats.

The role emphasizes TMF approval and QC review, resolving document issues, and maintaining robust document management practices using eTMF systems.