Remote TMF Operations Associate II

Worldwide Clinical Trials; Barcelona; Presencial; EUR 25.000 - 38.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials in Barcelona seeks a TMF Records Management Associate to support documentation, indexing and editing with strict naming conventions.

You will review, classify and process essential documents, perform quality control checks, and ensure alignment with regulatory and ICH GCP standards.

This role offers exposure to global TMF workflows, collaboration with project teams, and a path to develop clinical records expertise in a dynamic CRO environment.

Formación

• Data collection, indexing and editing following standardized naming conventions.
• Excellent written and verbal communication skills.
• Strong interpersonal skills in a fast-paced, deadline-driven environment.
• Ability to manage multiple, highly detailed tasks with accuracy and planning.
• Proficiency in Word and Excel; basic eTMF familiarity.
• General understanding of clinical research principles and processes.

Responsabilidades

• Fulfil TMF Approver and/or TMF QC Reviewer roles as SOP-defined.
• Process, review and resolve rejected TMF documents for complex studies.
• Prepare periodic TMF Quality Control checklists for Project Team review.
• Perform periodic TMF QC to ensure regulatory and ICH GCP adherence.
• Work with electronic TMF systems to review, classify and process essential documents.

Conocimientos

Data collection

Indexing

Editing

Communication skills

Interpersonal skills

Organizational skills

Microsoft Word

Microsoft Excel

eTMF

Clinical research knowledge

Educación

University Degree preferred (Life Science desirable)

Herramientas

Microsoft Word

Microsoft Excel

Descripción del empleo

Worldwide Clinical Trials in Barcelona seeks a TMF Records Management Associate to support documentation, indexing and editing with strict naming conventions.

You will review, classify and process essential documents, perform quality control checks, and ensure alignment with regulatory and ICH GCP standards.

This role offers exposure to global TMF workflows, collaboration with project teams, and a path to develop clinical records expertise in a dynamic CRO environment.