TMF Operations Specialist I

Worldwide Clinical Trials; Argentina; Presencial; ARS 67.336.036 - 97.263.164; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a TMF Records Management professional to support the Records Management Compliance Department in handling trial master file documents with accuracy and timeliness.

You will process, review, and resolve TMF documents, work with electronic systems, escalate quality issues, and provide admin support to the RMC Lead to help ensure regulatory compliance across studies. This role requires clear communication and meticulous data handling.

Formación

• Minimum 6 months of TMF experience in a regulated setting.
• Familiarity with eTMF and document repositories.
• Strong written and verbal communication skills.

Responsabilidades

• Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
• Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format.
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
• Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to RMC Lead.
• Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
• Perform additional tasks as assigned by their Line Manager.

Conocimientos

TMF Experience

Document control

Attention to detail

Regulatory awareness

Communication skills

Microsoft Word

Microsoft Excel

Educación

University Degree

Herramientas

Microsoft Word

Microsoft Excel

Descripción del empleo

Worldwide Clinical Trials is seeking a TMF Records Management professional to support the Records Management Compliance Department in handling trial master file documents with accuracy and timeliness.

You will process, review, and resolve TMF documents, work with electronic systems, escalate quality issues, and provide admin support to the RMC Lead to help ensure regulatory compliance across studies. This role requires clear communication and meticulous data handling.