TMF Operations Specialist — QC & Approvals

Worldwide Clinical Trials Limited; Polska; Híbrido; PLN 55.000 - 80.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials Limited is seeking a Records Management professional to support TMF Operations in a CRO environment. The role involves handling TMF Approver and QC Reviewer duties, reviewing and resolving TMF documents, and preparing quality control checklists to ensure regulatory adherence across electronic and paper records.

Applicants should bring familiarity with TMF processes, strong documentation skills, and the ability to work in a fast-paced setting while maintaining accuracy

Formación

• Ability to adhere to standardized document naming conventions.
• Excellent written and verbal communication.
• Strong interpersonal skills in fast-paced environments.
• Handle multiple, detailed tasks with accuracy.
• Demonstrate strong planning and organizational skills.
• Proficiency in MS Word and Excel.

Responsabilidades

• Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by SOPs.
• Process, review, and resolve rejected TMF documents for complex studies.
• Prepare periodic TMF Quality Control checklists for review by Project Team.
• Perform periodic TMF Quality Control to ensure regulatory compliance.
• Work with electronic and hard-copy TMF systems to review, classify and process documents.

Conocimientos

Data collection

Indexing

Communication skills

Interpersonal skills

Planning & organization

Word & Excel

eTMF knowledge

Clinical research basics

Educación

University degree

Herramientas

MS Word

MS Excel

Descripción del empleo

Worldwide Clinical Trials Limited is seeking a Records Management professional to support TMF Operations in a CRO environment. The role involves handling TMF Approver and QC Reviewer duties, reviewing and resolving TMF documents, and preparing quality control checklists to ensure regulatory adherence across electronic and paper records.

Applicants should bring familiarity with TMF processes, strong documentation skills, and the ability to work in a fast-paced setting while maintaining accuracy