TMF Operations Analyst II

Worldwide Clinical Trials; Barcelona; Presencial; EUR 28.000 - 42.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a TMF Operations professional to support TMF processes within our global CRO team. You will review and resolve TMF documents, maintain quality control checklists, and ensure regulatory compliance across studies from a global portfolio.

You will work with electronic TMF systems, ensure proper document naming, and collaborate with Project Teams to maintain accuracy and timeliness in TMF delivery.

Formación

• University Degree preferred (Life Science desirable).
• Up to 2-3 years of relevant TMF experience within the CRO/Pharma industry.
• Strong written and verbal communication skills.

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 and Sponsor portfolios.
• Prepare periodic TMF Quality Control checklists for Project Team review.
• Perform periodic TMF Quality Control to ensure regulatory and industry compliance.
• Work with Electronic Document Management and eTMF systems to review, classify and process documents.

Conocimientos

Data entry

Documentation

Microsoft Word

Excel

eTMF systems

Educación

University Degree

Herramientas

eTMF

Descripción del empleo

Worldwide Clinical Trials is seeking a TMF Operations professional to support TMF processes within our global CRO team. You will review and resolve TMF documents, maintain quality control checklists, and ensure regulatory compliance across studies from a global portfolio.

You will work with electronic TMF systems, ensure proper document naming, and collaborate with Project Teams to maintain accuracy and timeliness in TMF delivery.